Keywords
Pseudoexfoliation, prevalence, glaucoma, Postoperative complications, cataract, Pseudoexfoliation-syndrome, intra ocular pressure, rural population
This article is included in the Eye Health gateway.
This article is included in the Datta Meghe Institute of Higher Education and Research collection.
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.
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.
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.
Hospital statistics from India indicated that the percentage of patients with pseudoexfoliation, in addition to cataracts, ranges from 1.87% to 13.5%.
Pseudoexfoliation, prevalence, glaucoma, Postoperative complications, cataract, Pseudoexfoliation-syndrome, intra ocular pressure, rural population
We have updated and revised my whole manuscript as suggested by the peer reviewer. We have detailed the methodology of data collection for the study. We have also replaced the word prevalence with proportion in the given data. We have also written statistical formula details and references as asked by the reviewer. We have also updated the analysis and results part. We have changed the discussion part as opined by the reviewers.
See the authors' detailed response to the review by Ngozika Esther Ezinne
See the authors' detailed response to the review by Yuanbo Liang
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. The coexistence of cataract and pseudoexfoliation (PEX) syndrome presents unique surgical challenges. The accumulation of pseudoexfoliative material can weaken the zonular fibers that support the lens, increasing the risk of intraoperative complications such as lens dislocation. Inadequate pupillary dilation is common in PEX patients, necessitating the use of specialized surgical techniques and devices to ensure adequate visualization and access during surger.4
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.
Pseudoexfoliation syndrome is widely recognized as a significant risk factor for the development of glaucoma, particularly primary open-angle glaucoma. This association is primarily due to the accumulation of abnormal fibrillar extracellular material in various ocular structures, most notably within the trabecular meshwork. Over time, this buildup can interfere with the normal drainage of aqueous humor from the anterior chamber of the eye. As the outflow becomes increasingly obstructed, intraocular pressure rises, which is a key pathogenic factor in the development of glaucomatous optic neuropathy.
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
Understanding the clinical characteristics of these patients is crucial for developing effective management strategies and improving surgical outcomes. Therefore, this study aims to analyze the proportion of pseudoexfoliation among patients with cataracts visiting our hospital in a specific period, clinical profile, and association of pseudo-exfoliative glaucoma in patients with PXF in rural central India providing insights that could enhance patient care and inform public health initiatives in similar settings. The findings will contribute to better patient care strategies, improved surgical planning, and targeted public health interventions, ultimately enhancing visual outcomes and quality of life for affected individuals in resource-limited settings.
Study design - Cross-sectional study
Participants will be chosen from the Acharya Vinobha Bhave Hospital Sawangi, Meghe, Wardha, Maharashtra, for this hospital-based study. This single-center 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 study.
Candidates who visit AVBRH Sawangi and meet the inclusion and exclusion requirements are qualified to participate in this study.
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
The institutional ethics committee of the DMIMSU will authorize the study, following the principles of the Declaration of Helsinki.
• Patients with cataracts visiting the ophthalmology OPD will be selected based on inclusion and exclusion criteria.
• Informed consent will be obtained from all subjects after the nature of the study was explained to them.
• Consent will be in the local language to ensure validity.
• Relevant and detailed medical and ocular histories will be taken.
• Each participant will go through a thorough eye examination measuring their best corrected visual acuity with the Snellen chart, intraocular pressure, slit-lamp assessment, and fundus examination.
• Intraocular pressure (IOP) will be measured using a non-contact tonometer before pupil dilation. The IOP will be measured three times if it is higher than 21 mmHg.
• Gonioscopy will be done for every patient.
• After putting dilating drops (tropicamide plus) to dilate the pupil, the anterior segment and fundus examination will be done.
• A slit lamp will be used for anterior segment examination of the eye, searching for pseudoexfoliative material on the anterior segment structures.
• A fundus examination will be conducted using a slit lamp biomicroscopy or indirect ophthalmoscopy. The optic disc and retina will be examined.
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
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.
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
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.
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.
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.
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% = 0.05927
The desired margin error is 5%, or 0.05
n = 90
n = 90 patients needed in this study
Formula reference 8.
Observational research, known as a “cross-sectional study,” examines information gathered from a population or an appropriate group at a particular period.9 After collecting the demographical and ocular features data collection chi-square test will be applied and the significance of the clinical profile will be studied.
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. Clinical profiling of pseudoexfoliation in patients with cataracts will be done. Additionally, the frequency and association of pseudoexfoliative glaucoma will be studied.
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.
Shweta Kosamia et al (2016) conducted a study at MGM Hospital & Medical College, Aurangabad, and found the overall prevalence of PXF was 5.92%, with a higher occurrence in males (9.05%) compared to females (3.98%).7 The prevalence increased with age, peaking at 11.56% in the 61–70 years age group, with the youngest case reported at 55 years old. Among the 32 PXF cases, 78.1% resided in rural areas, and 53.1% had bilateral involvement. Intraocular pressure was normal (10–21 mmHg) in 96.9% of cases, with 3.1% having elevated IOP. Lens subluxation was noted in 3.1% of cases. PXF presents significant challenges, particularly in cataract surgery, due to zonular instability and poor pupillary dilation, emphasizing the need for early detection and careful surgical management to minimize complications.
Arvind H et al. (2003) conducted a population-based study in a rural area of southern India analyzed 2,850 individuals aged 40 years or older to assess the clinical profile of pseudoexfoliation syndrome (PXF). PXF was identified in 108 subjects (3.8%), with a significant increase in prevalence with age but no sex predilection. The condition was unilateral in 49.1% (53 cases) and bilateral in 50.9% (55 cases). Elevated intraocular pressure (>21 mm Hg) was found in 16.7% (18 cases), while 14.8% (16 cases) had occludable angles, and 13% (14 cases) were diagnosed with pseudoexfoliation glaucoma.10
Panigrahi S et al. (2024) conducted A cross-sectional study conducted at Hitech Medical College and Hospital, Western Odisha, between January 1, 2021, and December 31, 2022, included 340 OPD patients to determine the prevalence of pseudoexfoliation syndrome (PEX) and associated cataract characteristics. The study found that 74 out of 340 patients (23%) had PEX, with a higher prevalence in males (58%, 42 cases) compared to females (42%, 32 cases), resulting in a male-to-female ratio of 1.3:1. The mean age of presentation was 67 years (range 51–84 years), with the highest prevalence (41%) in the 61–70 years age group. Increased intraocular pressure (IOP) was observed in 11 cases (15%), while two patients each had open-angle glaucoma and lens-induced glaucoma. The most common cataract type among PEX patients was nuclear cataract (27%), followed by cortical cataract with nuclear sclerosis (19%). The findings indicate that PEX is more common in males and is strongly associated with increasing age, with nuclear cataract being the most prevalent form of cataract in PEX patients.11
This population-based cross-sectional study in rural southern India assessed the prevalence and risk factors of pseudoexfoliation (PXF) among 5,150 individuals aged 40 and above. The overall prevalence of PXF was 6.0%, increasing significantly with age and being more common in males. Of those with PXF, 25.7% were bilaterally blind despite correction, mostly due to cataracts. Glaucoma was present in 7.5% of PXF cases, and PXF was seen in 26.7% of primary open-angle glaucoma patients. Age and male gender were independently associated with PXF. Given its association with glaucoma and cataract-related complications, targeted screening for PXF in older adults may help reduce vision loss in this population.12
According to hospital records from India, the incidence of PXF ranges from 1.87% to 13.5%.13 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.14
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.15
Pseudoexfoliation is known to weaken the zonular fibers, making them more susceptible to stress and leading to partial or complete dislocation of the lens. This can pose significant surgical challenges, including poor capsular support, difficulty in lens nucleus manipulation, increased risk of capsular rupture, and the need for alternative intraocular lens (IOL) fixation techniques. Proper preoperative assessment using anterior segment optical coherence tomography (AS-OCT) or ultrasound biomicroscopy (UBM) can help evaluate zonular integrity and guide the surgical approach.
Given these complexities, cataract surgery in PEX patients with lens subluxation requires meticulous surgical planning, use of pupil expansion devices, careful phacoemulsification techniques, and postoperative monitoring for complications such as intraocular pressure spikes, corneal decompensation, and late IOL decentration. These cases emphasize the need for a multidisciplinary approach and individualized surgical strategies to achieve the best possible visual outcomes while minimizing complications. Therefore understanding the clinical characteristics of these patients is crucial for developing effective management strategies and improving surgical outcomes and, providing insights that could enhance patient care and inform public health initiatives in similar settings.
The results will be presented at a national conference and published in an indexed journal.
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.
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
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.
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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
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
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.
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
Alongside their report, reviewers assign a status to the article:
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