Changes in tear film function in patients after pterygium excision surgery done under topical anaesthesia with and without conjunctival autograft – A protocol for a randomized interventional study

Raina Jain; Pravin K. Tidake

doi:10.12688/f1000research.140868.1

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Study Protocol

Changes in tear film function in patients after pterygium excision surgery done under topical anaesthesia with and without conjunctival autograft – A protocol for a randomized interventional study

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

Raina Jain ¹, Pravin K. Tidake²

PUBLISHED 26 Sep 2023

Author details Author details

¹ Ophthalmology, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India
² Ophthalmology, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India

Raina Jain
Roles: Conceptualization, Methodology, Resources, Writing – Original Draft Preparation

Pravin K. Tidake
Roles: Supervision, Validation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

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

Abstract

Background: Pterygium is an extra-ocular disorder related to progressive subepithelial growth of degenerative conjunctival tissue over the cornea. There are multifactorial causes that lead to the growth of pterygium. The tear film becomes unstable due to the degenerative growth of the conjunctiva. The tear film is divided into three different layers. The lipid layer is secreted by the meibomian gland, which is the exterior layer exposed to the environment and prevents tears from drying out too rapidly. The lacrimal gland releases the middle layer, the aqueous layer, which provides oxygen to the corneal epithelial layer. The goblet cells secrete mucus, the innermost layer that makes the corneal epithelium hydrophilic. Due to uneven wettability brought on by the progression of pterygium, the tear film becomes unstable and may damage the ocular surface. It has been found that pterygium excision increases tear film stability. According to a study, the incidence of pterygium in central rural India is 12.9%. Incidence increases with age, gender, and occupation.
Methods: The patients with pterygium will be divided into two groups for the pterygium excision surgery: Group 1 consists of patients in which conjunctival autograft will not be done after pterygium excision, and Group 2 consists of patients in which conjunctival autograft will be done after pterygium excision. Preoperatively and postoperatively, visual acuity was assessed in all the patients on day 1, 4 weeks, and 8 weeks on follow-up. Tear film evaluation was done through Tear film Break Up Time (T-BUT) and Schirmer’s Test in patients preoperatively and postoperatively on day 1, 4 weeks, and 8 weeks follow up.
CTRI Registration: REF/2023/07/071130 (30/07/2023)
Protocol version: v1 dated 7/08/2023

Keywords

Pterygium, Tear film, Schirmer’s Test, Tear film Break Up Time, Conjunctival autograft, Dry Eye, Meibomian gland.

Corresponding author: Raina Jain

Competing interests: No competing interests were disclosed.

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

Copyright: © 2023 Jain R and Tidake PK. 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: Jain R and Tidake PK. Changes in tear film function in patients after pterygium excision surgery done under topical anaesthesia with and without conjunctival autograft – A protocol for a randomized interventional study [version 1; peer review: 1 approved with reservations]. F1000Research 2023, 12:1218 (https://doi.org/10.12688/f1000research.140868.1) First published: 26 Sep 2023, 12:1218 (https://doi.org/10.12688/f1000research.140868.1) Latest published: 26 Sep 2023, 12:1218 (https://doi.org/10.12688/f1000research.140868.1)

Introduction

The subepithelial fibrovascular growth of the degenerative bulbar conjunctival tissue that extends to the cornea is known as pterygium. It may result in impaired cosmesis, diminished vision due to astigmatism caused by growth along the pupillary axis, disruption of the precorneal tear film, and persistent discomfort.¹

The prevalence range of pterygium is 0.7% to 31% globally.² It is roughly 13% prevalent in rural areas of central India. It is predominately observed in men in tropical and subtropical areas.²^,³ The occurrence of pterygium is higher in equatorial countries because of higher exposure to ultraviolet (UV) light from the sun.⁴ Ultraviolet light causes hyperplasia and thickening in subconjunctival tissue due to damage to Bowmans’s membrane. The prevalence of pterygium in outdoor workers is comparatively more.⁴ Other potential contributing variables include age, sunlight, genetic factors, chronic inflammation, microtrauma, and dry eye.⁵ Low-grade pterygium may not cause symptoms but can lead to irritation, discomfort, impaired vision, induced astigmatism, and foreign body sensation.⁶ The epithelium of the cornea is considered hydrophobic as it is made of a lipophilic substance. So adequate surfactant is required in aqueous substance to wet the corneal surface. Proteins dissolved in tear film reduce surface tension and help it spread over the surface properly.⁷

Precorneal tear film can be divided into three parts. The lipid layer is produced by the meibomian glands. The lacrimal gland produces the aqueous layer, which provides the corneal epithelium with oxygen. The goblet cells secrete the inner mucous layer, which is responsible for the hydrophilic nature of corneal epithelium.⁸ Abnormal tear films are seen in patients with degenerative disease of the conjunctiva.⁹ Despite the significance of tear volume in pterygium patients, several studies have concluded with no change in tear volume and decreased tear output.¹⁰

According to Wanzeler ACV et al., pterygium causes a significant effect on the surface of the eye because it directly alters meibomian gland patterns, which can cause discomfort and signs of dysfunction.¹¹ Tear osmolarity increased in pterygium-affected eyes; the quantity and quality of tear film deteriorated while the number of goblet cells dropped.¹² Several investigations are available for diagnosing dry eye, out of which Schirmer’s test and TBUT are commonly used due to their easy availability and cost-effectiveness. The TBUT test evaluates the tear film's quality.¹³^,¹⁴ Rose Bengal staining detects damaged epithelial cells, which serves as an indirect indicator of decreased tear volume. The more the aqueous deficit, the more the degree of staining. Conjunctival impression cytology (CIC) tests the viability of the conjunctiva.¹⁵ Schirmer's and T-BUT levels are lower in pterygium-affected eyes, relating a link between abnormalities of ocular surface and tear film.¹⁶^,¹⁷ Lower value TBUT is related to unstable tear films. Tear film stability can be measured rather quickly and simply with the TBUT. Keratograph 5M helps in the non-invasive evaluation of tear film with the help of the Placido concentric circles image. Images taken by Keratograph 5M allow us to measure tear meniscus height in millimetres. Meibomian gland function is assessed using a Keratograph 5M. The meiboscan infrared equipment was used to assess the gland. Infrared images of meibography of the meibomian glands were assessed by applying Meiboscore.¹¹

Using Schirmer’s test and T-BUT, the evaluation is cheap, cost-effective, and reproducible. While the other methods will require the availability of instruments and are time-consuming.

The growth of pterygium is associated with the disruption of the integrity of the tear film. The disrupted tear film will cause ocular dryness, astigmatism, discomfort, and grittiness. Schirmer's test and tear film breakup time are two techniques for tear film evaluation. Tear film after pterygium excision surgery with and without conjunctival autograft will be evaluated postoperatively. This study will help to assess the postoperative complication and will enhance the already existing knowledge in the management of dry eye diseases in pterygium patients.

This protocol is reported inline with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.¹⁹

Aim

Changes in tear film function in patients after pterygium excision surgery done under topical anaesthesia with and without conjunctival autograft.

Objectives

1) To assess the function of the tear film in patients with unilateral pterygium and unaffected other eye.
2) To assess the change in tear film function in postoperative patients of pterygium excision under topical anaesthesia with and without conjunctival autograft using Schirmer’s test I and II.
3) Tostudy the ocular surface through fluorescein staining and measuring tear film break up time.

Protocol

Study setting

This is a two-arm, open-labelled, non-randomized interventional study. It will take place over 2 years (August 2022 – August 2024). Study was conducted in Out-Patient Department of Ophthalmology, Acharya Vinobha Bhave Rural Hospital Sawangi (Meghe), Wardha, Maharashtra, after receiving approval from the Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research.

All the patients who will be coming the O.P.D from August 2022 to August 2024 with unilateral pterygium of all age groups will be included in the study with routine admissions and with proper information about benefits of surgery andafter considering inclusion and exclusion criteria and taking informed consent for surgery and follow-up.

Sample

Sample size calculation

Sample size formula for difference between two mean

n = (2α + 2β) 2 (σ1 2 + σ2 21 k) Δ 2

Where Zα is the level of significance at 5%, i.e., 95% confidence interval = 1.96

Z β is the power of test = 80% = 0.84

Σ1 = S.D. of TBUT in diseased eye Pre-test = 3.4

Σ2 = S.D. of TUBT in diseased eye Post-test = 2.7

Δ = difference between two means. = 12.8 – 9.9 = 2.9

K = 1

\begin{array}{c} n = (1.96 + .84) 2 (3.42 + 2.72 / 1) 2.92 = 17.57 \\ = 20 patients needed in each group \end{array}

Angli Manhan et al’s¹⁶ study is used for reference in our study.

Software used: R-software version 4.3.2

Inclusion criteria

1) Patients who presented with a unilateral primary pterygium were observed.
2) The comparison of tear film was made between the eye having pterygium and the other eye being considered as control.
3) Patient who were willing for surgery.
4) Patients willing for postoperative follow-up.

Exclusion criteria

1) Patients having a systemic disease that leads to dry eye example: Sjogren’s syndrome.
2) Patients on medication like psychotropics and diuretics that cause ocular surface dryness.
3) Patients using contact lenses.
4) Patients with adnexal, anterior, or posterior segment diseases that affect the stability and secretion of the tear film.
5) Patients who underwent ocular surgery recently.
6) Patients using antiglaucoma drops, which cause ocular dryness.
7) Patients having recurrent pterygium or bilateral pterygium.
8) Patients who did not give consent for surgery.
9) Patients who did not come for follow up regularly.

Procedure

After the enrolment of the subject in study, participants in the study will be split into two arms. Arm A (patients undergoing pterygium excision surgery combined with conjunctival autograft) and Arm B (patients with pterygium excision undergone without conjunctival autograft), randomly assigned for a 1:1 allocation with the intention for treatment. Subjects will be invited and screened as part of the study's inclusion process. For subject allocation, a randomization procedure using a computer-generated list will be used. Patients will undergo surgery. Participants will be assessed on day 1, 4 weeks, and 8 weeks postoperatively to assess primary and secondary parameters.

Firstly, a thorough history of the symptoms will be taken, including their onset, duration, and any exacerbating factors. Secondly, a routine physical examination which will include blood investigations for complete blood count (CBC), random blood sugar, Electrocardiography (E.C.G) and Chest X-Ray will be performed on the patients. Thirdly, a comprehensive ocular examination will be performed on each patient, which includes the following procedures: a) Examination of the anterior segment of the eye involving the cornea, iris, pupil, lens, and eyelids. B) Evaluation of near vision and distant vision. The following examinations will be carried out in both eyes:

Schirmer’s test:

(a) Schirmer’s test- 1 (Without anaesthesia): This test helps in evaluation of aqueous deficiency in patients with dry eye by measuring reflex tear secretion after stimulation of conjunctiva. The reflex tear secretion is measured with the help of Whatman filter paper 41. It is placed at junction of middle and lateral one third of lower lid. The amount of wettability is measured in millimetre. If the reading is less than 10 mm, then aqueous tear deficiency is likely present.
(b) Basal Secretion/SCH-2 (After anaesthesia).

In the dim light room, the patient will undergo examination under a slit lamp, followed by Schirmer's test and Tear Film Break Up Time evaluation which is described below. At the intersection of the lateral 1/3 and medial 2/3, the lower palpebral conjunctiva was gently covered by a Schirmer strip that was folded at the notch. Ask the patient to sustain an open eyelid and regular blink pattern. Five minutes later, the strip was removed and measured in mm for the amount of wettability. After five minutes, if the wetness length was less than 10 mm, the Schirmer's-1 test—which does not involve anesthesia—was considered positive. Schirmer's tear test filter strips, also known as Whatmann no. 41 filter paper strips, which are 35 x 5 mm and folded 5 mm from one end, were the commercially available material utilized.

Following anesthesia, Schirmer's test (Basal secretion) was conducted similarly to the SCH-1 procedure but followed topical proparacaine 0.5%.

Tear film break up time (TBUT):

The cornea was first stained with fluorescein for this test, and then ophthalmic evaluation was under a red-free blue filter-lit slit lamp (Appasawamy LED Slit lamp AIA-11). The time between the first dry spots on the tear film and the lid blink is recorded. The average of the three recordings determined the TBUT. An average TBUT of less than 10 seconds indicated a positive result. Contact with the cornea was avoided to prevent excessive reflex tear production.

Operative procedure:

Every patient was recommended to instil topical antibiotic eye drops four times a day before surgery. All patients granted their consent after being informed about the surgery. Every patient underwent laboratory testing, such as haemoglobin (Hb), blood sugar, and coagulation profile.

A universal eye speculum was used to open the eye. Paracaine was used as a topical anaesthetic. Pterygium was dissected 4mm from the limbus to reveal the bare sclera. Using conjunctival scissors, fibrovascular tissue was dissected from the adjacent conjunctiva. The thickened conjunctiva and the tenon capsule below the conjunctiva were removed. The spontaneous process of haemostasis was achieved without the need for cautery. The further procedure would be different in both the groups. Group 1 was left with bare sclera and group 2 was proceeded with conjunctival autograft. The defect's size was measured using a calliper. A donor conjunctival graft, primarily obtained from the bulbar conjunctiva superiorly, was applied to the bare sclera. The original direction of the juxta-limbal boundary was carefully preserved. A lens spatula applied slight pressure to the free graft for eight to ten minutes to maintain its position. The bandage was left on for a whole day.

Postoperative care:

After a day, the bandage was removed, and topical application of a combination of antibiotic (Moxifloxacin 0.5%) and steroid (Dexamethasone 0.1%) eye drops combination formulation was prescribed. The drops were instilled four times a day for the first two weeks, tapered off to two times a day during the next 1 week and finally halted.

Following surgery, patients were not advised artificial tear drops. Following surgery, all patients were monitored on day one, one month, and two months. Schirmer's test and TBUT were done two months after surgery and they were given refraction on follow up visit. On every follow up, complications will be noted, if any and will be managed accordingly. For follow up visit routine camps were organized in the same places and patients were given spectacles free of cost on follow up. The patients who did not show up for follow up were considered drop outs from the study.

Control group

Tear film evaluation will be done in the control eye with the help of Schirmer’s Test I and II and Tear Film Break Up Time.

Outcomes

Primary outcome

1) Evaluation of tear film function by using Schirmer’s test I and II.-
The evaluation of tear film by using a Schirmer’s strip in the control eye should be more than 10 mm.
If the reading is less than 10mm, then Schirmer's test is considered positive.
2) Tear film evaluation using Tear Film Break Up Time-
Three readings were observed. If the mean value was less than 10 seconds, then the TBUT is considered positive for the presence of dry eye.

Secondary outcome

1) Evaluation of improvement in visual acuity after pterygium excision.
2) Complications of pterygium surgery include lid oedema, haemorrhage, and displaced graft.

Data analysis

All the results for the outcome variables will be presented in tables and will be described over descriptive statistics. No blinding will be done in the study. Outcome variables (tear film evaluation by Schirmer’s test and Tear Film Break Up Time, visual acuity) will be firstly tested for normality for the quantitative measurement of mean and standard deviation (SD). Positional average (Median) statistics will be used to find out for skewed distributions and calculating the interquartile range (IQR). All the binary and catergorical variables will be described over the frequency and percentages for qualitative assessment. Results will be calculated using R-software free version 4.3.2 for all statistical analysis.

The inferential statistics for testing the significant difference over the outcome variables will be evaluated at 5% level of significance (p ≤ 0.05)

Outcome Variable:- Baseline to endline visit assessment for pre operative procedure in comparison for two groups (pterygium excision done with conjunctival autograft and excision done without conjunctival autograft) over the measurement score for mean of primary variable (tear film evaluation by Schirmer’s test and Tear Film Break Up Time, visual acuity) will be evaluated for finding significance in mean using Anova or Kruskal wallis test for more than 2 assessment period. Post-hoc (Tuckey’s or Dunccan) test will be used to find the significance difference between two group for pair-wise comparison. Outcome variables will be tested for intra difference in measurement at pre & post visits using paired t-test for finding the significance in mean. While for inter group difference unpaired t- test for comparison of two group. Generalised models for repeated measures will be tested for different visit periods (within the group) & for comparison of two groups (between the group) to find fixed & random effects.

For non-normal distribution Mathematical algorithms will be used for conversion of the data to normal distribution. If Data over primary variable still follows the non normal distribution then we will use alternate non parametric test (Chi square, Mann Whitney, Wilcoxon test, Kruskal wallis, Friedmann test). If data for the outcome variable for testing normality results with non normal distribution for the quantitative assessment, it will be converted for normal distribution following mathematical algorithm, besides if data persists with non normal distribution we will use alternate non parametric test (Chi square, Mann Whitney, Wilcoxon test, Kruskal wallis, Friedmann test).

Following Categorial distribution will be graded for scoring system (Binary):

Schirmer’s test value of less than 10mm is considered positive.

TBUT of less than 10 seconds is considered positive.

Assessment of visual acuity will be done through Snellen’s Chart.

Chi square analysis will be performed for categorial evaluation between two groups pterygium excision done with conjunctival autograft and excision done without conjunctival autograft for statistical evidence of finding significance on Schirmer’s test less than 10mm considered as positive against normal& TBUT of less than 10 seconds considered as positive against normal at 5% l.o.s.(P = < 0.05).

t-test unpaired or alternative non parametric test will be used for finding significance at 5% l.o.s. (P = < 0.05) between groups pterygium excision done with conjunctival autograft and excision done without conjunctival autograft

Scope

This study will help in assessment in the changes in tear film in the patients with pterygium and the change in tear film occurring after the excision of pterygium with and without conjunctival autograft. This study will also help to evaluate the better surgical method.

Dissemination

To publish the study outcome in an esteemed journal and present findings at a National Conference on completion of study.

Study status

Patients are yet to be recruited.

Discussion

Manhas et al. in their study, found that tear film breakup time has a more diagnostic value than Schirmer's test II. They found that the TBUT test was abnormal in 21.11% of control eyes and 47.78% of pterygium patients. Their research concluded that the Schirmer's-2 test's statistical sensitivity was determined to be 24.4%, while its specificity was 90%. In eyes with pterygium, the TBUT test exhibited a sensitivity of 47.7% and a specificity of 78.8%, demonstrating that it was more sensitive than Schirmer's test performed under anaesthesia. Two months after surgery, the average TBUT was 12.8 + 2.7 seconds. This was a statistically significant improvement (p-value = 0.0001) from the preoperative readings.¹⁶

In a study by Shili Wang et al., the mean TBUT in the eyes with pterygium was determined to be 9.89 + 3.95 seconds before surgery. Four weeks after the operation, the TBUT value was 12.78 + 4.12 seconds; eight weeks later, it was 14.27 + 3.80 seconds. The two values were significantly different from those prior to surgery (p = 0.028 and p = 0.013). The final TBUT readings at the conclusion of the research period revealed a statistically significant improvement in the TBUT values, consistent with our investigation's anticipated outcomes.¹⁷

In the study conducted by Patkar P, Sune P on 100 patients, the preoperative Schirmer's value which was 13.00±2.47 mm was found to be increased to 14.39±2.34 mm, 14.78±2.11 mm and 14.78±2.11 mm, respectively on postoperative day 10th, 30th, and 60th. On preoperative day and postoperative day 10, the Schirmer's I value was significantly different (p-value 0.0001).¹⁸

The mean Schirmer's I measurement increased after the pterygium surgery in the study conducted by Neeraj Sharma et al., which found that following pterygium removal, the mean preoperative Tear Breakup Time (TBUT) increased from 7.212 seconds to 13.059 seconds, which is statistically significant.¹⁹ Statistically comparable postoperative improvement was seen in both groups. Postoperative outcomes were statistically superior in the conjunctival autograft group compared to those without graft. This is a similar outcome expected in our study⁸

Ethical considerations

Ethical committee approval from the DMIHER was issued DMIMS (DU)/IEC/2022/201on 28 August 2022. There was no involvement of animals Considering all the ethical values, informed consent was taken from all the subjects involved. The aim of the research will be explained to each participant. The lead investigator will obtain both written and verbal informed consent from each participant before the intervention. The Helsinki Declaration of 1975, mentioned in 2008, shall be followed for all procedures in this investigation.

The study documentation will be treated as confidential information and safely archived with only the principal investigator having access. Incase of any adverse effect, reporting will be done to the investigator and the subject will be treated accordingly and will be considered as drop out from the study.

Data availability

Underlying data

No data is associated with this article.

Reporting guidelines

Zenodo: SPIRIT checklist for ‘Changes in tear film function in patients after pterygium excision surgery done under topical anaesthesia with and without conjunctival autograft – A protocol for a randomized interventional study’. https://doi.org/10.5281/zenodo.8338924.¹⁹

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Acknowledgements

I want to express gratitude to all personnel at the Department of Ophthalmology in JNMC, AVBRH, Sawangi, Wardha, Maharashtra, India for their assistance in the study and analysis of the data.

References

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8. Sharma N, Sehrawat S, Sharma S: Comparative Analysis of Tear Film Parameters in Patients Undergoing Pterygium Excision by Conjunctival Autograft or Bare Sclera Technique Augmented by Intraoperative Mitomycin C Application. JCDR. 2022 [cited 2023 Jul 29]. Reference Source
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Version 1

VERSION 1 PUBLISHED 26 Sep 2023

Author details Author details

¹ Ophthalmology, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India
² Ophthalmology, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India

Raina Jain
Roles: Conceptualization, Methodology, Resources, Writing – Original Draft Preparation

Pravin K. Tidake
Roles: 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 (1)

version 1

Published: 26 Sep 2023, 12:1218

https://doi.org/10.12688/f1000research.140868.1

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© 2023 Jain R and Tidake PK. 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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Jain R and Tidake PK. Changes in tear film function in patients after pterygium excision surgery done under topical anaesthesia with and without conjunctival autograft – A protocol for a randomized interventional study [version 1; peer review: 1 approved with reservations]. F1000Research 2023, 12:1218 (https://doi.org/10.12688/f1000research.140868.1)

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Open Peer Review

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PUBLISHED 26 Sep 2023

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Reviewer Report 27 Dec 2023

Chizoba Udoka Uba-Obiano, Nnamdi Azikiwe University, Awka, Anambra, Nigeria

Approved with Reservations

https://doi.org/10.5256/f1000research.154270.r219379

1. The title is long, although it summarizes the study (27 words). I would suggest this: CHANGES IN TEAR FILM FUNCTION AFTER PTERYGIUM EXCISION WITH AND WITHOUT CONJUNCTIVAL AUTOGRAFT: A PROTOCOL FOR A RANDOMISED INTERVENTIONAL STUDY.

2. ... Continue reading

1. The title is long, although it summarizes the study (27 words). I would suggest this: CHANGES IN TEAR FILM FUNCTION AFTER PTERYGIUM EXCISION WITH AND WITHOUT CONJUNCTIVAL AUTOGRAFT: A PROTOCOL FOR A RANDOMISED INTERVENTIONAL STUDY.

2. The abstract should provide an informative and balanced summary of what would be done.
The background of the abstract should be summarized in one or two sentences. It is long and not well coordinated.
The aim or objective of the study is not stated.
The method should be explained briefly.

3. The research needs to state the aim or objective of the study as the closing statement in the introduction.

4. Methods: Since this is a study protocol, the method should be in future tenses and not past tense. It is important to state that randomization will be done and how the patients will be selected and assigned to each group.

5. Key words should be reduced to three in number: Pterygium, tear film function. conjunctival autograft.

6. The research should also state the reason for selecting conjunctival autograft, any effect on tear film, and back this up with studies.

7. The researcher may lose some patients to follow. How will this be prevented? state.

8. Recheck or rephrase: low-grade pterygium (which classification is this in paragraph 2?) kindly state or reference. Also, rephrase sentences on lines 9, 10, and 11.

9. Rephrase the sentences in paragraph 4, lines 2–9; they are rather short sentences that can be merged, and they will follow sequentially.

10. Aim: To determine the changes in tear film function before and after pterygium excision surgery done under topical anaesthesia with and without conjunctival autograft.

11. Objectives should be clearly stated:
i. to assess tear film function in eyes with unilateral pterygium and the eyes without pterygium using Schirmer's test and TBUT
ii. to assess the change in tear film function after pterygium excision using Schirmer's test.
iii. to assess the change in tear film function after pterygium excision using tear film break-up time.
iv. to assess the ocular surface changes using fluorescein staining. (This fourth objective should be removed.)

12. Protocol: why write non-randomized when the topic already bears a randomized study?
Rephrase the sentences written in this section. Stick to future tenses.
Suggestion: Patients of all age groups who will present to the outpatient clinic from August 2022 - August 2024 with unilateral pterygium will be included in the study. The eligibility criteria will be considered with proper information about the benefits of surgery explained to the patient. Written informed consent for the surgery and follow-up will also be obtained. The patients will be admitted accordingly.

13. The sample size is small for the study: 20 in each group. Look for another study that can provide a larger sample size.

14. The listed inclusion criteria should be present or future tenses. Also, remove No. 2 from the list.

15. Exclusion criteria:
No. 1: patient WITH
NO. 9: patients who will be willing to come for follow-up regularly.

16. Procedure: Arm B (patient UNDERGOING pterygium excision without conjunctival autograft)
Paragraph 2: eyelids, cornea, iris, and pupils in this order.
line 3: at the junction of the medial 2/3rd and lateral 1/3rd of the lower lid.

17. Recheck this statement: if the reading is less than 10mm, then aqueous tear deficiency is LIKELY present

18. Why Schirmer tests I and II?
Choose one, preferably Schirmer test I.

19. Correction: The patient will be asked to sustain open eyelids with a regular blink pattern. 5 minutes later, the strip will be removed.

20. Correction: ARE the commercially available materials that will be utilized.

21. Correction: the time between the lid blink and the appearance of the dry spot on the corneal surface.

22. What type of fluorescein will be used? paper fluorescein strip? it should be moistened with sterile water to prevent irritation.

23. Operative procedures should be described in the future tense.

24. Post-op care: paragraph 2, line 2, sentence 2: Schirmer's test and TBUT will be done on each follow-up visit.

25. Correction: Tear film evaluation will also be done in the control eyes using Schirmer tests and TBUT.

26. Correction in Scope: This study will help to assess tear film changes ..........

27. The Vancouver referencing style should be maintained.

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

Partly
Is the study design appropriate for the research question?

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

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

Not applicable

References

1. Jain R, Tidake P: Changes in tear film function in patients after pterygium excision surgery done under topical anaesthesia with and without conjunctival autograft – A protocol for a randomized interventional study. F1000Research. 2023; 12. Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: General Ophthalmology.

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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VERSION 1 PUBLISHED 26 Sep 2023

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Version 1 26 Sep 23	read

Chizoba Udoka Uba-Obiano, Nnamdi Azikiwe University, Awka, Nigeria

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Reviewer Report

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27 Dec 2023 | for Version 1

Chizoba Udoka Uba-Obiano, Nnamdi Azikiwe University, Awka, Anambra, Nigeria

4 Views Cite this report Responses(0)

Approved With Reservations

1. The title is long, although it summarizes the study (27 words). I would suggest this: CHANGES IN TEAR FILM FUNCTION AFTER PTERYGIUM EXCISION WITH AND WITHOUT CONJUNCTIVAL AUTOGRAFT: A PROTOCOL FOR A RANDOMISED INTERVENTIONAL STUDY.

2. The abstract should provide an informative and balanced summary of what would be done.
The background of the abstract should be summarized in one or two sentences. It is long and not well coordinated.
The aim or objective of the study is not stated.
The method should be explained briefly.

3. The research needs to state the aim or objective of the study as the closing statement in the introduction.

4. Methods: Since this is a study protocol, the method should be in future tenses and not past tense. It is important to state that randomization will be done and how the patients will be selected and assigned to each group.

5. Key words should be reduced to three in number: Pterygium, tear film function. conjunctival autograft.

6. The research should also state the reason for selecting conjunctival autograft, any effect on tear film, and back this up with studies.

7. The researcher may lose some patients to follow. How will this be prevented? state.

8. Recheck or rephrase: low-grade pterygium (which classification is this in paragraph 2?) kindly state or reference. Also, rephrase sentences on lines 9, 10, and 11.

9. Rephrase the sentences in paragraph 4, lines 2–9; they are rather short sentences that can be merged, and they will follow sequentially.

10. Aim: To determine the changes in tear film function before and after pterygium excision surgery done under topical anaesthesia with and without conjunctival autograft.

11. Objectives should be clearly stated:
i. to assess tear film function in eyes with unilateral pterygium and the eyes without pterygium using Schirmer's test and TBUT
ii. to assess the change in tear film function after pterygium excision using Schirmer's test.
iii. to assess the change in tear film function after pterygium excision using tear film break-up time.
iv. to assess the ocular surface changes using fluorescein staining. (This fourth objective should be removed.)

12. Protocol: why write non-randomized when the topic already bears a randomized study?
Rephrase the sentences written in this section. Stick to future tenses.
Suggestion: Patients of all age groups who will present to the outpatient clinic from August 2022 - August 2024 with unilateral pterygium will be included in the study. The eligibility criteria will be considered with proper information about the benefits of surgery explained to the patient. Written informed consent for the surgery and follow-up will also be obtained. The patients will be admitted accordingly.

13. The sample size is small for the study: 20 in each group. Look for another study that can provide a larger sample size.

14. The listed inclusion criteria should be present or future tenses. Also, remove No. 2 from the list.

15. Exclusion criteria:
No. 1: patient WITH
NO. 9: patients who will be willing to come for follow-up regularly.

16. Procedure: Arm B (patient UNDERGOING pterygium excision without conjunctival autograft)
Paragraph 2: eyelids, cornea, iris, and pupils in this order.
line 3: at the junction of the medial 2/3rd and lateral 1/3rd of the lower lid.

17. Recheck this statement: if the reading is less than 10mm, then aqueous tear deficiency is LIKELY present

18. Why Schirmer tests I and II?
Choose one, preferably Schirmer test I.

19. Correction: The patient will be asked to sustain open eyelids with a regular blink pattern. 5 minutes later, the strip will be removed.

20. Correction: ARE the commercially available materials that will be utilized.

21. Correction: the time between the lid blink and the appearance of the dry spot on the corneal surface.

22. What type of fluorescein will be used? paper fluorescein strip? it should be moistened with sterile water to prevent irritation.

23. Operative procedures should be described in the future tense.

24. Post-op care: paragraph 2, line 2, sentence 2: Schirmer's test and TBUT will be done on each follow-up visit.

25. Correction: Tear film evaluation will also be done in the control eyes using Schirmer tests and TBUT.

26. Correction in Scope: This study will help to assess tear film changes ..........

27. The Vancouver referencing style should be maintained.

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

Partly
Is the study design appropriate for the research question?

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

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

Not applicable

References

1. Jain R, Tidake P: Changes in tear film function in patients after pterygium excision surgery done under topical anaesthesia with and without conjunctival autograft – A protocol for a randomized interventional study. F1000Research. 2023; 12. Publisher Full Text

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

General Ophthalmology.

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.

Respond to this report

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[1] 1. Mutlu F: A comparative study of recurrent pterygium surgery Limbal conjunctival autograft transplantation versus mitomycin C with conjunctival flap. Ophthalmology. 1999 Apr 1; 106(4): 817–821. PubMed Abstract | Publisher Full Text

[2] 2. Detels R, Dhir SP: Pterygium: A Geographical Study. Arch. Ophthalmol. 1967 Oct 1; 78(4): 485–491. Publisher Full Text

[3] 3. Hill JC, Maske R: Pathogenesis of pterygium. Eye. 1989 Mar; 3(2): 218–226. Publisher Full Text

[4] 4. Hilgers JHC: Pterygium: Its Incidence, Heredity and Etiology*. Am. J. Ophthalmol. 1960 Oct; 50(4): 635–644. Publisher Full Text

[5] 5. Türkyılmaz K, Öner V, Sevim MŞ, et al.: Effect of Pterygium Surgery on Tear Osmolarity. J. Ophthalmol. 2013 Jan 20; 2013: 1–5. Publisher Full Text

[6] 6. Saw SM, Tan D: Pterygium: prevalence, demography and risk factors. Ophthalmic Epidemiol. 1999 Jan; 6(3): 219–228. Publisher Full Text

[7] 7. Lemp MA: The Precorneal Tear Film: I. Factors in Spreading and Maintaining a Continuous Tear Film Over the Corneal Surface. Arch. Ophthalmol. 1970 Jan 1; 83(1): 89. Publisher Full Text

[8] 8. Sharma N, Sehrawat S, Sharma S: Comparative Analysis of Tear Film Parameters in Patients Undergoing Pterygium Excision by Conjunctival Autograft or Bare Sclera Technique Augmented by Intraoperative Mitomycin C Application. JCDR. 2022 [cited 2023 Jul 29]. Reference Source

[9] 9. Oguz H, Karadede S, Bitiren M, et al.: Tear functions in patients with pinguecula. Acta Ophthalmol. Scand. 2001 Jun; 79(3): 262–265. PubMed Abstract | Publisher Full Text

[10] 10. Chaidaroon W, Pongmoragot N: Basic tear secretion measurement in pterygium. J. Med. Assoc. Thail. 2003 Apr; 86(4): 348–352. PubMed Abstract

[11] 11. Wanzeler ACV, Barbosa IAF, Duarte B, et al.: Impact of pterygium on the ocular surface and meibomian glands. Shukla D, editor. PLoS One. 2019 Sep 12; 14(9): e0213956. PubMed Abstract | Publisher Full Text | Free Full Text

[12] 12. Safarzadeh M, Heidari S, Azizzadeh P, et al.: Comparative assessment of tear function tests, tear osmolarity, and conjunctival impression cytology between patients with pterygium and healthy eyes. J. Ophthalmic Vis. Res. 2019; 14(1): 11. Publisher Full Text

[13] 13. Senchyna M, Wax MB: Quantitative assessment of tear production: A review of methods and utility in dry eye drug discovery. J. Ocul. Biol. Dis. inform. 2008 Mar; 1(1): 1–6. Publisher Full Text

[14] 14. Ganeshpuri AS, Kamble BS, Patil P, et al.: A Comparative Study of Tear Film Stability & Secretion in Pterygium Patients - Diabetic vs. Non-diabetic. Int. J. Health Sci. 2014; (4).

[15] 15. Singh R: Impression cytology of the ocular surface. Br. J. Ophthalmol. 2005 Dec 1; 89(12): 1655–1659. PubMed Abstract | Publisher Full Text | Free Full Text

[16] 16. Manhas A, Gupta D, Manhas RS, et al.: Comparison of Tear Film Breakup Time with Schirmer's Test with Anesthesia to Detect Tear Film Abnormality in Patients with Pterygium - A Study from Jammu and Kashmir.2017; 5: 3.

[17] 17. Wang S, Jiang B, Gu Y: Changes of tear film function after pterygium operation. Ophthalmic Res. 2011; 45(4): 210–215. PubMed Abstract | Publisher Full Text

[18] 18. Patkar P, Sune P: Evaluation of Tear Film Functions Preoperatively and Postoperatively in Cases with Pterygium: A Case Control Study. J. Clin. Diagn. Res. 2020 Jan 1; 14. Publisher Full Text

[19] 19. Dr Jain R , Dr Tidake P : Changes in tear film function in patients after pterygium excision surgery done under topical anesthesia with and without conjunctival autograft. (Version v1). Zenodo. 2023. Publisher Full Text

Changes in tear film function in patients after pterygium excision surgery done under topical anaesthesia with and without conjunctival autograft – A protocol for a randomized interventional study

Abstract

Keywords

Introduction

Aim

Objectives

Protocol

Study setting

Sample

Inclusion criteria

Exclusion criteria

Procedure

Outcomes

Primary outcome

Secondary outcome

Data analysis

Scope

Dissemination

Study status

Discussion

Ethical considerations

Data availability

Underlying data

Reporting guidelines

Acknowledgements

References

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