A study of clinical profile in patients of cataracts with pseudoexfoliation in rural populations of central India

Yuga Pawar; Archana Thool

doi:10.12688/f1000research.149563.1

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Study Protocol

A study of clinical profile in patients of cataracts with pseudoexfoliation in rural populations of central India

[version 1; peer review: 2 approved with reservations]

Yuga Pawar ¹, Archana Thool¹

PUBLISHED 17 May 2024

Author details Author details

¹ Ophthalmology, Jawaharlal Nehru Medical College; Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India

Yuga Pawar
Roles: Conceptualization, Resources, Writing – Original Draft Preparation, Writing – Review & Editing

Archana Thool
Roles: Conceptualization, Supervision, Validation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Eye Health gateway.

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background

Ophthalmologists deal with daily pseudoexfoliation (PXF) due to severe secondary glaucoma, which arises after cataract surgery. Cataracts with pseudoexfoliation are age-related and are associated with open-angle glaucoma. Therefore, pseudoexfoliation is expected to occur more frequently. Pseudoexfoliation is occasionally associated with the development of thick nuclear cataracts, which may make surgery challenging. risks of cataract extraction in patients with pseudoexfoliation include zonular weakness and inadequate pupillary dilation. This may cause vitreous loss, and intraoperative or postoperative lens displacement. It could also lead to a rise in postoperative intraocular pressure (IOP), progressing to long-term inflammation, phimosis of the capsular tissue, glaucoma, and surgical corneal decompensation. Recurrent secondary cataracts are typically caused by some remaining cortical tissue and decreased zonular support, which may lead to lens epithelial cell migration. Surgery for glaucoma and cataracts is complicated by the presence of pseudoexfoliative debris.

Objectives

To determine the prevalence of pseudoexfoliation in cataract patients visiting the ophthalmic OPD, AVBRH hospital, to locate patients with pseudoexfoliative cataracts, to evaluate their likelihood of progressing to open-angle glaucoma, and to examine the various ocular characteristics of these patients.

Methodology

The study participants will undergo ophthalmological examination after considering the inclusion and exclusion criteria. This examination will include sac syringing on the lacrimal gland, estimation of the highest corrected visual acuity, slit-lamp examination, application tonometer assessment of intraocular pressure (IOP), and fundus examination using an indirect ophthalmoscope. All individuals with cataracts visiting the ophthalmology department of AVBRH will be examined under a slit-lamp to determine the presence of pseudoexfoliation in the operating eye.

Expected Results

Hospital statistics from India indicated that the percentage of patients with pseudoexfoliation, in addition to cataracts, ranges from 1.87% to 13.5%.

Keywords

Pseudoexfoliation, prevalence, glaucoma, Postoperative complications, cataract, Pseudoexfoliation-syndrome, intra ocular pressure, rural population

Corresponding author: Yuga Pawar

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2024 Pawar Y and Thool A. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Pawar Y and Thool A. A study of clinical profile in patients of cataracts with pseudoexfoliation in rural populations of central India [version 1; peer review: 2 approved with reservations]. F1000Research 2024, 13:483 (https://doi.org/10.12688/f1000research.149563.1) First published: 17 May 2024, 13:483 (https://doi.org/10.12688/f1000research.149563.1) Latest published: 16 May 2025, 13:483 (https://doi.org/10.12688/f1000research.149563.2)

Introduction

Background

A systemic condition known as pseudoexfoliation (PXF) syndrome was initially noted by Finnish ophthalmologist Lindberg in 1917, and Alfred Vogt provided more data in 1923. The development of a whitish-grey fibrogranular amyloid-like substance on the corneal endothelium, pupillary margin on the iris, anterior portion of the lens capsule, zonules, ciliary body, anterior vitreous, and trabecular meshwork are indicators of age-related ocular disorder pseudoexfoliation (PXF) syndrome.¹ Histologically, Fibrillin is an elastin that creates elastic fibers, and fibrils are non-collagenous materials.² According to histological analysis, the deposits are composed of laminin, glycosaminoglycans, and hyaluronic acid coatings on fibrils, a non-collagenous component utilized to create the basement membrane.

“Three-Ring Sign” is frequently seen on the anterior lens capsule consisting of an outer region that is granularly foggy, an essentially uniform center region, and a clear zone in the middle.

White-gray flaky debris on the anterior side of the lens or the pupillary border of the iris is the most widely recognized and easily identifiable diagnostic sign of pseudoexfoliation.³ The diagnosis is supported by pigment deposition in the anterior chamber structures and pigment loss from the iris sphincter area. The examiner was primarily responsible for providing an accurate diagnosis of pseudo-exfoliation. Pseudoexfoliation syndrome can remain undiagnosed due to the absence of early signs. Identifying pseudoexfoliation during routine ophthalmic examinations is crucial because it can increase the risk of problems during cataract surgery owing to two clinical symptoms: zonular weakening and inadequate pupil dilation. These patients have a five-fold increased risk of developing intraoperative complications such as corneal decompensation,secondary Cataract, capsular phimosis, posterior capsular rupture, zonular dialysis and vitreous loss.²

Open-angle glaucoma with pseudoexfoliation (PXF) is a moderately frequent type of glaucoma that can result in an abnormally high eye pressure. This disorder is identified by the presence of a dust-like substance on the surface of the iris and lens inside the eye. The trabecular meshwork, which is the drainage system of the eye, also becomes coated with this “fibrillar” material, raising intraocular pressure. Growing research also suggests that other organs within the body are affected by this basement membrane disease. Although pseudoexfoliation tends to be extraordinarily asymmetrical and is most frequently found in adults aged > 70 years, it can also occur in one or both eyes. Pseudoexfoliation, despite being long believed to be an illness only affecting persons of Scandinavian origin, glaucoma is now present in all ethnic groups.

The anterior lens capsule and pupillary edge are often covered in pseudoexfoliative material. Pseudoexfoliation syndrome, which includes weak zonules, posterior synechiae, dislocation of the lens, and poor or deficient pupillary dilation, is thought to be among the leading causes of ocular hypertension, early cataract development, and secondary open-angle glaucoma.⁴ PEG may result from congestion of the trabecular meshwork, according to specific theories. Less zonular support and some lingering cortical tissue often cause secondary cataracts by allowing lens epithelial cells to migrate. The abundance of pseudoexfoliative matter in the anterior area has made cataract and glaucoma surgeries more challenging. The more frequent secondary cataract is typically caused by less zonular support and some remaining cortical tissue, which allows the lens epithelial cells to migrate. The anterior portion contains pseudoexfoliative material, which complicates surgical operations for cataracts and glaucoma.

Cataract surgeries may be difficult because of the changes that pseudoexfoliative deposits cause in the anterior segment tissues. Tissue changes may result in vitreous loss, capsular phimosis, intraoperative or postoperative lens displacement, protracted inflammation following surgery, spikes in intraocular pressure (IOP) that cause damage to the glaucomatous disc, or postoperative corneal decompensation. Research has shown that compared to normal cases, patients with PXF syndrome are five times more likely to experience intraoperative problems after cataract surgery. Therefore, in patients with pseudoexfoliation syndrome, appropriate preoperative workup and intraoperative care will lower the risk of complications during cataract surgery.⁵ A comparison of intraoperative, postoperative, and visual outcomes in patients with and without pseudoexfoliation following cataract surgery is not yet available. Thus, the aim of our study was to compare surgical outcomes (intraoperative problems, postoperative problems, and visual results) among patients.

Aims and objectives

1. To know the prevalence of pseudoexfoliation in cataract patients, visiting to AVBRH hospital.
2. To determine how common open-angle glaucoma is among cataract patients who have pseudoexfoliation
3. To study the various ocular features in patients of cataracts with pseudoexfoliation.

Methods

Study design - Cross-sectional study

Setting

Participants will be chosen from the Acharya Vinobha Bhave Hospital Sawangi, Meghe, Wardha, Maharashtra, for this hospital-based study. The study will follow the guidelines of the Helsinki Declaration and will obtain institutional ethics committee approval from DMIMSU. All volunteers will be asked for written consent signed by them after being informed of the study’s purpose and any potential adverse effects. The procedure site will be the Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi, Department of Ophthalmology. After considering the inclusion and exclusion criteria, all cataract patients who visited the ophthalmology department of AVBRH will be chosen for surgery.

Eligibility criteria

Candidates who visit AVBRH Sawangi and meet the inclusion and exclusion requirements are qualified to participate in this study.

Inclusion criteria

1. Patients of cataract with psuedoexfoliation of age 50 years and above
2. Patient who is willing to provide informed consent.

Exclusion criteria

1. Traumatic cataract
2. Congenital or developmental cataract
3. Complicated cataract, which includes lens-induced, subluxated lens, etc.
4. Previous intraocular surgery
5. Age younger than 50 years
6. Patients lost to follow-up
7. Long-term use of topical medication
8. Patients with diabetes mellitus
9. Patients with Pterygium
10. Chronic uveitis

Data sources

The institutional ethics committee of the DMIMSU will authorize the study, following the principles of the Declaration of Helsinki. Ophthalmology OPD patients with cataracts will be selected according to the inclusion and exclusion criteria. Informed consent will be obtained from all subjects after the nature of the study is explained. Consent was provided in the local language to ensure validity. Relevant and detailed medical and ocular history will be obtained, and a torchlight examination will be performed. Each participant will undergo a thorough eye examination measuring their intraocular pressure, highest corrected visual acuity with the Snellen chart, slit-lamp assessment, and fundus examination. Intraocular pressure (IOP) was tracked using an application tonometer before pupil dilation under topical anesthesia. IOP will be measured three times in a row if it is higher than 21 mmHg. Fundus examination will be done to observe the retina and optic nerve. Correlation of all data will be performed.

General vital statistics such as pulse and blood pressure will be recorded. Systemic examination will be done. A detailed history will be taken for each patient, best corrected visual acuity (BCVA) will be noted, and a slit lamp will be used to perform a comprehensive anterior segment examination of the eye, including the cornea, anterior chamber, iris, pupil, and lens.⁴ Following pupillary dilation, a comprehensive fundus examination will be conducted using a +90 Diopter lens, employing slit-lamp biomicroscopy and indirect ophthalmoscopy. Cataracts will also evaluated and graded using a slit-lamp examination. An applanation tonometer or non-contact tonometer will be used to measuring intraocular pressure. After dilating drops (tropicamide plus) to dilate the pupil, the fundus and anterior segment will be inspected to view the retina and optic nerve. The objective of the evaluation was to identify pseudoexfoliative material on the cornea, iris, lens, and pupil, among other parts of the eye. The optic disc will be evaluated using a 90-D lens.

The following factors will be taken into account while diagnosing glaucoma:

An imbalance in the cup-to-disc ratio of the two eyes (> 0.2).

A regional notch or thinned neuroretina rim.

Higher cup-to-disc ratios (>0.5), particularly when the cups are aligned with the vertical axis.

A paler retinal nerve margin

Acquired cupping which is defined by vascular indications, such as the ’overpass’ of central vessels and the barring of circumlunar vessels

Bias

Observational bias: Observational bias can be minimized by examining the patients by the same examiner.

Objective bias: Objective bias can be minimized by using the same slit lamp for each patient vising the ophthalmic OPD.

Outcomes

Primary outcome

1. Intraocular pressure
Intraocular pressure (IOP) is the fluid pressure in the eye. As pressure is a measure of force per area, IOP is a measure of the magnitude of the force exerted by aqueous humor on the internal surface area of the anterior eye. Each normal eye produces about 2 μl of aqueous solution per minute, that is, about 70 l during the course of a lifetime. Normal intraocular pressure is 10-21 mmHg, but it can drop as low as 0 mmHg in hypotony and can exceed 70 mmHg in some glaucomas.
2. Characteristics of the lens
Pseudoexfoliation syndrome is a chronic age-related disorder of the extracellular matrix that results in the deposition of abnormal fibrillary (pseudoexfoliative) material within various body tissues. This condition primarily manifests in the anterior segment of the eye. The intraocular lens shoes poor dilation with peri-pupillary transillumination defect, fibrillar white flaky deposits on the anterior lens capsule (Hoarfrost Ring), and fibrillar white flaky deposits on the pupillary border.

Secondary outcome

1. Atrophic patches on the iris

Iris atrophy is a very rare, progressive disorder of the eye characterized by a pupil that is out of place and/or distorted areas of degeneration on the iris (atrophy) and/or holes in the iris. This disorder develops slowly over time in pseudo-exfoliation syndrome.

2. Phacodonesis

Phacodonesis is present if the lens trembles upon movement of the eye during slit-lamp examination. The zonular apparatus is the main support system of the human lens, and weakness in the zonules can cause instability of the lens, leading to complications during cataract extraction surgery.

Quantitative variable

1. Patient will be selected on the basis of inclusion and exclusion criteria
2. After obtaining consent, patients will be examined for the highest corrected visual acuity with the Snellen chart, and intraocular pressure > 21 mmHg will be considered as raised.
3. During slit-lamp assessment, dilated pupils with cataracts with pseudoexfoliative material on the anterior lens capsule or pupillary margins or iris or anterior chamber will be considered as having cataract with pseudoexfoliation.
4. On fundus examination, the difference between cup-to-disc ratios of both eyes is more than 0.2, regional notch or thinned neuroretina rim, higher cup: disc ratios (>0.5), particularly when the cups are aligned with the vertical axis, a paler retinal nerve margin will be considered as an eye with glaucomatous changes.

Sample size calculation

To calculate the sample size

n = \frac{Z^{2} P (1 - P)}{d^{2}}

Where, n = sample size,

Z = Z statistic for a level of confidence,

P = Expected prevalence or proportion

(If the expected prevalence is 20%, then P = 0.2), and

d = Precision (if the precision is 5%, then d = 0.05).⁶

Z is the threshold of significance at 5%, which is equal to 1.95 with a 95% confidence interval.

P = prevalence of patients of cataract with pseudoexfoliation = 5.92% = 0.0529

The desired margin error is 5%, or 0.05

\begin{array}{c} n = {(1.96)}^{2} \times 0.0592 \times (1 - 0.0592) / {(0.05)}^{2} \\ = 85.58 \end{array}

n = 90

n = 90 patients needed in this study

Formula reference – Daniel et al.

Analysis

Observational research, known as a “cross-sectional study,” examines information gathered from a population or an appropriate group at a particular period.⁷

Expected results

After collecting the data of patients with cataracts with pseudoexfoliation syndrome out of the total patients visiting the AVBRH Ophthalmology OPD over a span of 2 years, the prevalence will be calculated according to a cross-sectional study.

Discussion

Ophthalmologists deal with pseudoexfoliation (PXF) conditions on a regular basis because of severe secondary glaucoma and problems that arise after cataract surgery. Despite the fact that it has been recognized since the beginning of the 20th century, interest in its study has only grown in the past several decades. A total of 540 individuals of either sex who visited the ophthalmology outpatient department at MGM Hospital and Medical College in Aurangabad and were 45 years of age or older were included in this study.⁸

There are only two publications on the frequency of pseudoexfoliation syndrome in India, according to a literature search. In the first, published in 1968 by Sood and Ratnaraj, the prevalence in patients with pseudoexfoliation was observed to be 34% and 1.87% in those 45 years of age or older.⁹ The most recent study on this topic was conducted in 1984 by Lamba and Giridhar,¹⁰ who found that 7.4% of patients with pseudoexfoliation also had glaucoma. These two studies were conducted in hospitals. These two studies were conducted in hospitals. This is the only population-based study on pseudoexfoliation syndrome conducted in India.¹¹ Subjects with pseudoexfoliation had a mean IOP that was 1.29 mmHg greater than those without pseudoexfoliation. The 95% confidence intervals somewhat overlapped, yet this difference was nonetheless significant. Of the individuals with pseudoexfoliation, 16.7% had high intraocular pressure. Slightly over three percent patients had ocular hypertension, or elevated IOP without glaucomatous optic neuropathy in 13% of pseudoexfoliative instances, glaucomatous optic neuropathy was discovered. Prior research on pseudoexfoliation has almost always demonstrated a correlation between increased intraocular pressure (IOP) and glaucoma.

According to hospital records from India, the incidence of PXF ranges from 1.87% to 13.5%.¹² The current study found that 5.92% of participants had pseudoexfoliation syndrome. There were more men than women in this population. It has been observed that PXF becomes more common as people age. Most patients with PXF live in rural areas. Pseudoexfoliation was more common among the patients who participated in outdoor activities. In 100 consecutive PEX patients, Kozart and Yanoff conducted a clinic-based investigation and found that glaucoma was 7% common and ocular hypertension 15% common. in their investigation, however, elevated IOP was required for the diagnosis of glaucomaSimilar to our results, the Blue Mountains Eye research revealed 9.3% OHT and 14.2% glaucoma. This population-based study used optic neuropathy with or without elevated IOP to diagnose pseudoexfoliative glaucoma. Pseudoexfoliation syndrome is known to cause IOP spikes, which may not appear in a single IOP record.¹³

A wide range of significant ocular and surgical consequences can result from pseudoexfoliation syndrome. Principally, zonular instability and, to a lesser extent, inadequate pupillary dilatation can cause complications associated with cataract surgery. Therefore, awareness of the structural and functional aspects of this condition may aid in preventing or reducing most of them. The percentage of successful surgical operations has increased since the early diagnosis of the illness owing to meticulous attention to surgical awareness, postoperative follow-up, and preoperative preparation.¹¹

In a population-based investigation conducted in rural southern India in 2003, Arvind et al. examined the pseudoexfoliation profile. They found that the incidence increased significantly with age; however, there was no sex preference. Persons with pseudoexfolition had a much greater frequency of cataracts than persons without PXF (p = 0.014).¹²

Rutviben Ravjibhai Sadatia1, Nisha Ahuja2, Vegada Bhavisha3, Raghunathan Iodine4, and Kurian Abraham5 conducted a prospective interventional study in rural areas of Western India. The mean age of the patients was 62.48 (±5.62) years in the pseudoexfoliatin group and 60.7 (±7.63) years in the group without pseudoexfoliation (p = 0.1870). The anterior lens capsule (n = 49), pupillary edge (n = 19), and corneal endothelium (n = 2) were the most prevalent sites of pseudoexfoliative deposits in the pseudoexfoliation group. There was no statistically significant changes in the IOP or pupillary dilatation.⁹

The Aravind Comprehensive Eye Survey (ACES) is a population-based prevalence study of ocular disorders that impair vision, including glaucoma, carried out in a rural population in three districts in the southern Indian state of Tamil Nadu: Madurai, Tirunelveli, and Tuticorin, which are 40 years of age or older. According to the methodology and research design, the prevalence of pseudoexfoliation was 6.0% (5.3, 6.6) with a 95% confidence interval. The frequency was higher in males (p=0.01) and increased with age (p <0.001After optimal correction; 25.7% of pseudoexfoliative participants were still bilaterally blind, with cataracts accounting for 89.3% of this blindnessSeventy-five percent of the participants with pseudoexfoliation had glaucoma, and 26.7% of those with primary open-angle glaucoma had exfoliation.¹¹

The following consequences are the subject of clinical-histopathologic correlations: lens involvement (PEX-phacopathy), zonular apparatus involvement (zonulopathy), iris involvement (iridopathy), trabecular meshwork involvement (trabeculopathy), ciliary body involvement (cyclopathy),and cornea involvement (corneal endotheliopathy): (1) angle-closure glaucoma and open-angle glaucoma brought on by ciliary and pupillary block; (2) changes to the zonular apparatus and its insertion into the ciliary body and lens during extracapsular cataract surgery can result in phacodonesis, lens displacement, and an increased incidence of vitreous loss; (3) breakdown of the blood-aqueous barrier (pseudouveitis), production of posterior synechiae owing to involvement of all iris cell populations, anterior chamber hypoxia, iris stromal bleeding, pigment epithelium melanin dispersion, inadequate or asymmetric pupillary dilatation; and (4) A damaged and numerically decreased endothelium explains early diffuse corneal endothelial decompensation.¹⁴

Dissemination

The results will be presented at a national conference and published in an indexed journal.

Study status

The recruitment procedure is still in the early stages.

Ethics and consent

The research protocol got approval from the Datta Meghe Institute of Higher Education and Research (Deemed to be University) Institutional ethical committee in the meeting held on 31-03-2023 with DMIHER (DU)/IEC/2023/877.

All the participants will be educated about the research, and written and verbal informed consent will be obtained from all the participants before the intervention.

Data availability

No data are associated with this article.

Repository name: Figshare

File name: STROBE check list for A STUDY OF CLINICAL PROFILE IN PATIENTS OF CATARACTS WITH PSEUDOEXFOLIATION IN RURAL POPULATIONS OF CENTRAL INDIA

DOI: 10.6084/m9.figshare.25391719

URL: https://figshare.com/account/items/25391719/edit

Acknowledgements

I would like to express my gratitude to Dr. Sachin Daigavane, HOD of the Ophthalmology Department, for his kind permission and unwavering support.

I am grateful to Mr. Laxmikant Umate Sir for assisting me in conducting data analysis and determining the sample size.

References

1. Ahmed KN: Outcome of Phaco Surgeries in Patients with Pseudoexfoliation. JOJ Ophthalmol. 2017 Nov 20 [cited 2023 Aug 1]; 5(4). Publisher Full Text Reference Source
2. Gupta RK, Sharma R, Gupta RK, et al.: Prevalence and Ocular Manifestations of Pseudoexfoliation Syndrome Among Patients Scheduled for Cataract Surgery in a Teaching Hospital in North India.2022; 9(2).
3. Manalil AG, Mishra P, Manavalan S, et al.: CATARACT SURGERY IN PSEUDOEXFOLIATION SYNDROME. J. Evol. Med. Dent. Sci. 2014 Oct 17; 3(54): 12403–12410. Publisher Full Text
4. Pseudoexfoliation Syndrome and Pseudoexfoliation Glaucoma: A Review of the Literature with Updates on Surgical Management.[cited 2023 Aug 1]. Reference Source
5. Data collection: Wikipedia.2023 [cited 2023 Aug 2]. Reference Source
6. 1509511098944.pdf: [cited 2023 Aug 2]. Reference Source
7. Sullivan K, Dean A, Soe MM: OpenEpi - a web-based epidemiologic and statistical calculator for public health. Public Health Rep. 2009; 124(3): 471–474. PubMed Abstract | Publisher Full Text | Free Full Text
8. IJCMAAS_NOV_2016_VOL12_ISS3_11.pdf: [cited 2023 Sep 29]. Reference Source
9. Arvind H, Raju P, Paul PG, et al.: Pseudoexfoliation in South India. Br. J. Ophthalmol. 2003 Nov; 87(11): 1321–1323. PubMed Abstract | Publisher Full Text | Free Full Text
10. Sadatia RR, Ahuja N, Bhavisha V, et al.: Surgical Outcomes of Pseudoexfoliation Syndrome among the Indian Rural Population Scheduled for Small Incision Cataract Surgery: A Prospective Interventional Study. Int. J. Anat. Radiol. Surg. 2022 [cited 2023 Oct 24]. Publisher Full Text Reference Source
11. Krishnadas R, Nirmalan PK, Ramakrishnan R, et al.: Pseudoexfoliation in a rural population of southern India: the Aravind Comprehensive Eye Survey. Am. J. Ophthalmol. 2003 Jun 1; 135(6): 830–837. PubMed Abstract | Publisher Full Text
12. Thomas R: Glaucoma in India: Current status and the road ahead. Indian J. Ophthalmol. 2011 Jan; 59 Suppl(Suppl1): S3–S4. PubMed Abstract | Publisher Full Text
13. Kozart DM, Yanoff M: Intraocular pressure status in 100 consecutive patients with exfoliation syndrome. Ophthalmology. 1982 Mar; 89(3): 214–218. PubMed Abstract | Publisher Full Text
14. Naumann GO, Schlötzer-Schrehardt U, Küchle M: Pseudoexfoliation syndrome for the comprehensive ophthalmologist. Intraocular and systemic manifestations. Ophthalmology. 1998 Jun; 105(6): 951–968. PubMed Abstract | Publisher Full Text

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Version 2

VERSION 2 PUBLISHED 17 May 2024

Author details Author details

¹ Ophthalmology, Jawaharlal Nehru Medical College; Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India

Yuga Pawar
Roles: Conceptualization, Resources, Writing – Original Draft Preparation, Writing – Review & Editing

Archana Thool
Roles: Conceptualization, Supervision, Validation, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (2)

version 2

Revised

Published: 16 May 2025, 13:483

https://doi.org/10.12688/f1000research.149563.2

version 1

Published: 17 May 2024, 13:483

https://doi.org/10.12688/f1000research.149563.1

© 2024 Pawar Y and Thool A. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Pawar Y and Thool A. A study of clinical profile in patients of cataracts with pseudoexfoliation in rural populations of central India [version 1; peer review: 2 approved with reservations]. F1000Research 2024, 13:483 (https://doi.org/10.12688/f1000research.149563.1)

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Open Peer Review

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Reviewer Report 13 Mar 2025

Ngozika Esther Ezinne, Discipline of Optometry, University of KwaZulu-Natal, Durban, South Africa; Optometry Unit, Department of Clinical Surgical Science, The University of the West Indies at St Augustine, Saint Augustine, Tunapuna/Piarco Municipal Corporation, Trinidad and Tobago

Approved with Reservations

https://doi.org/10.5256/f1000research.164042.r367674

Thank you for the opportunity to review this study. Please find my comments below:
Introduction

The background information provided is insufficient. It would be beneficial to include details on the previously recorded prevalence of the

Thank you for the opportunity to review this study. Please find my comments below:
Introduction

The background information provided is insufficient. It would be beneficial to include details on the previously recorded prevalence of the condition both globally and in the specific study area.
Additionally, the manuscript would benefit from an explanation of the mechanisms by which cataracts may lead to the condition or to open-angle glaucoma.

Methods

The manuscript requires a thorough review of its grammar.
The methods section should be presented narratively rather than in a list format to improve readability and clarity.
The study lacks detailed information on the steps taken for data collection. A more comprehensive description of the methodology is necessary.
It is unclear how participants will be recruited for the study. This needs to be clarified.
The sampling procedure is not specified. Please provide more information on how participants will be selected.
The manuscript does not mention potential confounding factors. It would be helpful to discuss any anticipated confounders and the strategies that will be employed to control for them.
It is not specified whether this will be a multicenter or single-center study. This distinction should be made clear.

Results

There is no information on how the results will be presented. It is important to include details on the data analysis and presentation methods.

Discussion

The discussion section should address the strengths and limitations of the study to provide a more balanced assessment of the findings.

Recommendation
Overall, the study has merit, but it requires significant revisions to meet the journal's standards. I recommend a major revision of the manuscript before it can be considered for indexing.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Ocular health, Diabetes, Ocular diseases, Binocular vision, children vision, rural health, public health, mental health.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Author Response 16 May 2025

Yuga Pawar, Ophthalmology, Jawaharlal Nehru Medical College; Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India

16 May 2025

Author Response

Thank you for suggesting the correction, I have provided data on the previously recorded prevalence of the condition and provided an explanation of the mechanisms by which cataracts with pseudoexfoliation ... Continue reading Thank you for suggesting the correction, I have provided data on the previously recorded prevalence of the condition and provided an explanation of the mechanisms by which cataracts with pseudoexfoliation may lead to open-angle glaucoma in the attached manuscript.

I have corrected my manuscript and have explained detailed information on the steps taken for data collection.

I have also recruited patients on the basis of inclusion and exclusion criteria.

Now I have also specified the sampling procedure.

All the corrections that you have specified are done and attached to the manuscript.

Thank you for your valuable corrections.

I have corrected and mentioned the additional points in the analysis and result as you have suggested in the attached manuscript.

I have also revised the discussion part.

Thank you so much for your valuable opinion regarding my study.
Thank you for suggesting the correction, I have provided data on the previously recorded prevalence of the condition and provided an explanation of the mechanisms by which cataracts with pseudoexfoliation may lead to open-angle glaucoma in the attached manuscript.

I have corrected my manuscript and have explained detailed information on the steps taken for data collection.

I have also recruited patients on the basis of inclusion and exclusion criteria.

Now I have also specified the sampling procedure.

All the corrections that you have specified are done and attached to the manuscript.

Thank you for your valuable corrections.

I have corrected and mentioned the additional points in the analysis and result as you have suggested in the attached manuscript.

I have also revised the discussion part.

Thank you so much for your valuable opinion regarding my study.
Competing Interests: No competing interests were disclosed. Close
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Author Response 16 May 2025

Yuga Pawar, Ophthalmology, Jawaharlal Nehru Medical College; Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India

16 May 2025

Author Response

Thank you for suggesting the correction, I have provided data on the previously recorded prevalence of the condition and provided an explanation of the mechanisms by which cataracts with pseudoexfoliation ... Continue reading Thank you for suggesting the correction, I have provided data on the previously recorded prevalence of the condition and provided an explanation of the mechanisms by which cataracts with pseudoexfoliation may lead to open-angle glaucoma in the attached manuscript.

I have corrected my manuscript and have explained detailed information on the steps taken for data collection.

I have also recruited patients on the basis of inclusion and exclusion criteria.

Now I have also specified the sampling procedure.

All the corrections that you have specified are done and attached to the manuscript.

Thank you for your valuable corrections.

I have corrected and mentioned the additional points in the analysis and result as you have suggested in the attached manuscript.

I have also revised the discussion part.

Thank you so much for your valuable opinion regarding my study.
Thank you for suggesting the correction, I have provided data on the previously recorded prevalence of the condition and provided an explanation of the mechanisms by which cataracts with pseudoexfoliation may lead to open-angle glaucoma in the attached manuscript.

I have corrected my manuscript and have explained detailed information on the steps taken for data collection.

I have also recruited patients on the basis of inclusion and exclusion criteria.

Now I have also specified the sampling procedure.

All the corrections that you have specified are done and attached to the manuscript.

Thank you for your valuable corrections.

I have corrected and mentioned the additional points in the analysis and result as you have suggested in the attached manuscript.

I have also revised the discussion part.

Thank you so much for your valuable opinion regarding my study.
Competing Interests: No competing interests were disclosed. Close
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Reviewer Report 20 Dec 2024

Yuanbo Liang, Wenzhou Medical University, Wenzhou, China

Approved with Reservations

https://doi.org/10.5256/f1000research.164042.r344696

This protocol show us a study of clinical profile in patients of cataracts with pseudoexfoliation in rural populations of central India which is interesting. And there are some recommendations for this protocol to clarify the protocol more clearly.
1. For the objective of the study，it seem confused. The aim mentioned in the introduction section of the article is different from that in the abstract. In the introduction part, the aim is "the aim of our study was to compare surgical outcomes (intraoperative problems, postoperative problems, and visual results) among patients." . In the abstract, the objective is "To determine the prevalence of pseudoexfoliation in cataract patients ...., to locate patients with pseudoexfoliative cataracts, to evaluate their likelihood of progressing to open-angle glaucoma, and to examine the various ocular characteristics of these patients. ". Please clarify it.
2. As the definition of prevalence, it is not suitable to use it as the percentage of PXF combined with cataract patients among the total cataract patients in this hospital.
3. In this protocol, the method may be not provided with sufficient details. A detailed flow chart of this study could be better for replication by others.
4. The P-value for the sample size calculation is 5.92%. Please provide more information about the source of this data.
5.Statistical methods for the collecting data is provvided. Please provide it.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: glaucoma

CITE

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Author Response 17 Feb 2025

Yuga Pawar, Ophthalmology, Jawaharlal Nehru Medical College; Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India

17 Feb 2025

Author Response

YES, I agree with your opinion and will correct it.
thank you for suggestion
Competing Interests: No competing interests were disclosed.
YES, I agree with your opinion and will correct it.
thank you for suggestion
YES, I agree with your opinion and will correct it.
thank you for suggestion
Competing Interests: No competing interests were disclosed. Close
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Author Response 16 May 2025

Yuga Pawar, Ophthalmology, Jawaharlal Nehru Medical College; Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India

16 May 2025

Author Response

Thank you for your suggestion.
My study is related to knowing the prevalence of pseudoexfoliation in patients with cataracts visiting our hospital, their clinical profiling, and the association of pseudoexfoliative ... Continue reading Thank you for your suggestion.
My study is related to knowing the prevalence of pseudoexfoliation in patients with cataracts visiting our hospital, their clinical profiling, and the association of pseudoexfoliative glaucoma among these patients. I have corrected the objectives of my study in the manuscript. You are right, as prevalence typically refers to the proportion of individuals in a population who have a specific disease or condition at a particular time or over a specified period. It's used in epidemiology to describe disease burden in a defined population. But as I am doing a hospital-based study, I should use proportion or frequency. I have corrected and maintained a detailed method of data collection in the attached manuscript. Thank you for correcting me. I have taken the reference of P-value from a similar study that was held in a tertiary care hospital. I have corrected my reference in the manuscript.
Thank you for your suggestion.
My study is related to knowing the prevalence of pseudoexfoliation in patients with cataracts visiting our hospital, their clinical profiling, and the association of pseudoexfoliative glaucoma among these patients. I have corrected the objectives of my study in the manuscript. You are right, as prevalence typically refers to the proportion of individuals in a population who have a specific disease or condition at a particular time or over a specified period. It's used in epidemiology to describe disease burden in a defined population. But as I am doing a hospital-based study, I should use proportion or frequency. I have corrected and maintained a detailed method of data collection in the attached manuscript. Thank you for correcting me. I have taken the reference of P-value from a similar study that was held in a tertiary care hospital. I have corrected my reference in the manuscript.
Competing Interests: No competing interests were disclosed. Close
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Author Response 17 Feb 2025

Yuga Pawar, Ophthalmology, Jawaharlal Nehru Medical College; Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India

17 Feb 2025

Author Response

YES, I agree with your opinion and will correct it.
thank you for suggestion
Competing Interests: No competing interests were disclosed.
YES, I agree with your opinion and will correct it.
thank you for suggestion
YES, I agree with your opinion and will correct it.
thank you for suggestion
Competing Interests: No competing interests were disclosed. Close
Report a concern
Author Response 16 May 2025

Yuga Pawar, Ophthalmology, Jawaharlal Nehru Medical College; Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India

16 May 2025

Author Response

Thank you for your suggestion.
My study is related to knowing the prevalence of pseudoexfoliation in patients with cataracts visiting our hospital, their clinical profiling, and the association of pseudoexfoliative ... Continue reading Thank you for your suggestion.
My study is related to knowing the prevalence of pseudoexfoliation in patients with cataracts visiting our hospital, their clinical profiling, and the association of pseudoexfoliative glaucoma among these patients. I have corrected the objectives of my study in the manuscript. You are right, as prevalence typically refers to the proportion of individuals in a population who have a specific disease or condition at a particular time or over a specified period. It's used in epidemiology to describe disease burden in a defined population. But as I am doing a hospital-based study, I should use proportion or frequency. I have corrected and maintained a detailed method of data collection in the attached manuscript. Thank you for correcting me. I have taken the reference of P-value from a similar study that was held in a tertiary care hospital. I have corrected my reference in the manuscript.
Thank you for your suggestion.
My study is related to knowing the prevalence of pseudoexfoliation in patients with cataracts visiting our hospital, their clinical profiling, and the association of pseudoexfoliative glaucoma among these patients. I have corrected the objectives of my study in the manuscript. You are right, as prevalence typically refers to the proportion of individuals in a population who have a specific disease or condition at a particular time or over a specified period. It's used in epidemiology to describe disease burden in a defined population. But as I am doing a hospital-based study, I should use proportion or frequency. I have corrected and maintained a detailed method of data collection in the attached manuscript. Thank you for correcting me. I have taken the reference of P-value from a similar study that was held in a tertiary care hospital. I have corrected my reference in the manuscript.
Competing Interests: No competing interests were disclosed. Close
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Version 2

VERSION 2 PUBLISHED 17 May 2024

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Version 2 (revision) 16 May 25			read	read
Version 1 17 May 24	read	read

Yuanbo Liang, Wenzhou Medical University, Wenzhou, China
Ngozika Esther Ezinne, University of KwaZulu-Natal, Durban, South Africa; The University of the West Indies at St Augustine, Saint Augustine, Trinidad and Tobago
Gazella Bruce Warjri, Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital, New Delhi, India
Bahjah Esehiyb, Omar Al-Mukhtar University, Albayda, Libya

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1 Views

18 Aug 2025 | for Version 2

Bahjah Esehiyb, Ophthalmology Department, Omar Al-Mukhtar University, Albayda, Jabal al Akhdar District, Libya

1 Views Cite this report Responses(0)

Approved With Reservations

I appreciate the chance to review this article Please find my comments below:
1- Objectives:
inconsistent objectives: the abstract and introduction are not properly matched. The objective should be to focus on association rather than "likelihood of progression," which requires a longitudinal study-type research.
2. Methodology:
Insufficient The criteria for diagnosis of PEX and PEX glaucoma lack detailed description (e.g., dilation status, bilaterality, iris signs, angle appearance), and diagnosis of glaucoma is ambiguous and not based on established guidelines.
Methodological contradictions:
The sampling method is not described.
Phacodonesis is listed as a secondary outcome, while lens subluxation is part of the exclusion ???.
It's unclear whether IOP was measured using non-contact or applanation tonometry.
Missing Key Variables:
No evaluation of visual field abnormalities (a critical component of glaucoma diagnosis), angle appearance, poor dilatation, or bilateral findings. There is no uniform grading or staging for glaucoma.
There are some certain corrections that are recommended for improving the clarity and clinical accuracy of the article.

Sac syringing correction: The phrase “sac syringing on the lacrimal gland” should be replaced by “sac syringing of the nasolacrimal duct,” as the lacrimal gland does not get involved in this procedure.
Clarify tonometry type: change the ambiguous phrase “application tonometer” to applanation tonometry (Goldmann or otherwise) or non-contact tonometry, and specify which method was used.
Add gonioscopy findings in the outcome measures: Gonioscopy findings (e.g., angle configuration, pseudoexfoliative material, trabecular pigmentation, Sampaolesi’s line) should be included in primary outcomes, as they help confirm open-angle mechanism in suspected PXG.
Standardize optic disc terminology: “Paler retinal nerve margin” should be changed to “pallor of the neuroretinal rim,” which is a standard clinical parameter of glaucomatous damage.
Update the descriptions of optic nerve changes in glaucoma by replacing terms like “overpass of central vessels” and “barring of circumlunar vessels” with clearer modern terms like nasalization of central vessels and baring of circumlinear vessels.
Improve glaucoma diagnostic criteria: Glaucoma diagnosis should be clearly based on recognized structural signs and qualified as “suspected” if visual field testing or OCT imaging is not available.
Harmonize term: Use either “PXF” or “PEX” consistently throughout the article to avoid confusion.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

opthalmology , Medical education

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1 Views

26 Jun 2025 | for Version 2

Gazella Bruce Warjri, Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital, New Delhi, India

1 Views Cite this report Responses(0)

Not Approved

There are numerous studies on the prevalence of pseudoexfoliation. This study will not add much to literature.
Introduction: The first line describing about Lindberg in 1917 has no reference. Reference has to be added.
The grammar and sentence structure of the whole manuscript has to be revised. Most of the manuscript doesn’t have any proper flow. At one point the authors describe pseudoexfoliation glaucoma and in the next sentence abruptly describe secondary cataracts. It makes no sense.
The authors have written the acronym of pseudoexfoliation as PXF in some places and as PEX in others. They should stick to one of the acronyms.
Introduction: “PEG”. The authors have not spelled out the acronym PEG in the manuscript.
2/3 of the sentences in the manuscript have no references attached. This reflects poorly on the writing quality of a scientific paper.
Methods: IOP should be checked by the gold standard, “Goldman applanation tonometer”.
Diagnosis of glaucoma: “Imbalance in cup-to-disc ratio of >0.2, higher CDR >0.5, paler retinal nerve margin”. Are all of these part of the diagnosis of glaucoma? According to which guidelines?
Exclusion criteria: subluxated lens: Many cases of pseudoexfoliation present as subluxated lens. Why should this be in the exclusion criteria?
Exclusion criteria: “Patients lost to follow up”. How can patients be lost to follow up in a cross sectional study??

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Glaucoma and Neuro-ophthalmology

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

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6 Views

13 Mar 2025 | for Version 1

6 Views Cite this report Responses(1)

Approved With Reservations

Thank you for the opportunity to review this study. Please find my comments below:
Introduction

The background information provided is insufficient. It would be beneficial to include details on the previously recorded prevalence of the condition both globally and in the specific study area.
Additionally, the manuscript would benefit from an explanation of the mechanisms by which cataracts may lead to the condition or to open-angle glaucoma.

Methods

The manuscript requires a thorough review of its grammar.
The methods section should be presented narratively rather than in a list format to improve readability and clarity.
The study lacks detailed information on the steps taken for data collection. A more comprehensive description of the methodology is necessary.
It is unclear how participants will be recruited for the study. This needs to be clarified.
The sampling procedure is not specified. Please provide more information on how participants will be selected.
The manuscript does not mention potential confounding factors. It would be helpful to discuss any anticipated confounders and the strategies that will be employed to control for them.
It is not specified whether this will be a multicenter or single-center study. This distinction should be made clear.

Results

There is no information on how the results will be presented. It is important to include details on the data analysis and presentation methods.

Discussion

The discussion section should address the strengths and limitations of the study to provide a more balanced assessment of the findings.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Ocular health, Diabetes, Ocular diseases, Binocular vision, children vision, rural health, public health, mental health.

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Author Response

16 May 2025

Yuga Pawar, Ophthalmology, Jawaharlal Nehru Medical College; Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India

Thank you for suggesting the correction, I have provided data on the previously recorded prevalence of the condition and provided an explanation of the mechanisms by which cataracts with pseudoexfoliation may lead to open-angle glaucoma in the attached manuscript.

I have corrected my manuscript and have explained detailed information on the steps taken for data collection.

I have also recruited patients on the basis of inclusion and exclusion criteria.

Now I have also specified the sampling procedure.

All the corrections that you have specified are done and attached to the manuscript.

Thank you for your valuable corrections.

I have corrected and mentioned the additional points in the analysis and result as you have suggested in the attached manuscript.

I have also revised the discussion part.

Thank you so much for your valuable opinion regarding my study.

View more View less

Competing Interests

No competing interests were disclosed.

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Reviewer Report

5 Views

20 Dec 2024 | for Version 1

Yuanbo Liang, Wenzhou Medical University, Wenzhou, China

5 Views Cite this report Responses(2)

Approved With Reservations

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

glaucoma

Respond to this report

Responses (2)

Author Response

16 May 2025

Yuga Pawar, Ophthalmology, Jawaharlal Nehru Medical College; Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India

Thank you for your suggestion.
My study is related to knowing the prevalence of pseudoexfoliation in patients with cataracts visiting our hospital, their clinical profiling, and the association of pseudoexfoliative glaucoma among these patients. I have corrected the objectives of my study in the manuscript. You are right, as prevalence typically refers to the proportion of individuals in a population who have a specific disease or condition at a particular time or over a specified period. It's used in epidemiology to describe disease burden in a defined population. But as I am doing a hospital-based study, I should use proportion or frequency. I have corrected and maintained a detailed method of data collection in the attached manuscript. Thank you for correcting me. I have taken the reference of P-value from a similar study that was held in a tertiary care hospital. I have corrected my reference in the manuscript.

View more View less

Competing Interests

No competing interests were disclosed.

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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[2] 2. Gupta RK, Sharma R, Gupta RK, et al.: Prevalence and Ocular Manifestations of Pseudoexfoliation Syndrome Among Patients Scheduled for Cataract Surgery in a Teaching Hospital in North India.2022; 9(2).

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A study of clinical profile in patients of cataracts with pseudoexfoliation in rural populations of central India

Abstract

Background

Objectives

Methodology

Expected Results

Keywords

Introduction

Background

Aims and objectives

Methods

Setting

Eligibility criteria

Inclusion criteria

Exclusion criteria

Data sources

Bias

Outcomes

Quantitative variable

Sample size calculation

Analysis

Expected results

Discussion

Dissemination

Study status

Ethics and consent

Data availability

Acknowledgements

References

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