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Clinical profile, visual outcome and quality of life in patients undergoing pan retinal photocoagulation for proliferative diabetic retinopathy

[version 1; peer review: 1 approved with reservations]
Meghavi Pandya
https://orcid.org/0009-0008-0579-2760
1, Shashank Banait1, Sachin Daigavane1
Meghavi Pandya
https://orcid.org/0009-0008-0579-2760
1, Shashank Banait1, Sachin Daigavane1
PUBLISHED 02 May 2024
Author details Author details
OPEN PEER REVIEW
REVIEWER STATUS

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

Abstract

Introduction

Visual outcomes and quality of life of individuals with proliferative diabetic retinopathy following pan-retinal photocoagulation (PRP) have only been briefly documented in a few publications. Improved quality of life experienced by patients as a result of PRP is directly associated with a positive impact on visual outcomes.

Aim

To determine whether visual outcomes and quality of life after PRP in diabetic patients would result in a better predictive image of the patient as a whole, thus boosting the success rates and efficacy of this treatment method.

Methods

P.R.P. was performed under topical anesthesia as defined by the early treatment diabetic retinopathy study (E.T.D.R.S.) guidelines.

Conclusion

This evidence-based analytical observational prospective study could aid in exploring the prognostic value of pan-retinal photocoagulation in proliferative diabetic retinopathy.

Keywords

Pan-retinal Photocoagulation, Proliferative Diabetic Retinopathy, Diabetes, Vision,

Corresponding authors: Meghavi Pandya, Shashank Banait, Sachin Daigavane
Competing interests: No competing interests were disclosed.
Grant information: The author(s) declared that no grants were involved in supporting this work.
Copyright:  © 2024 Pandya M et al. 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: Pandya M, Banait S and Daigavane S. Clinical profile, visual outcome and quality of life in patients undergoing pan retinal photocoagulation for proliferative diabetic retinopathy [version 1; peer review: 1 approved with reservations]. F1000Research 2024, 13:437 (https://doi.org/10.12688/f1000research.144879.1) First published: 02 May 2024, 13:437 (https://doi.org/10.12688/f1000research.144879.1) Latest published: 02 May 2024, 13:437 (https://doi.org/10.12688/f1000research.144879.1)

Introduction

Damage to the retina from diabetes can cause vision loss due to a condition known as diabetic retinopathy (DR), a microvascular abnormality caused by the long-term effects of diabetes mellitus. It is the leading cause of severe vision impairment among working-age adults in western countries. Avoiding diabetic retinopathy-related vision loss requires1 prompt diagnosis and easy treatment.

The non-proliferative retinopathy (NPDR) and proliferative retinopathy (PDR) stages of diabetic retinopathy are clinically distinguished from one another.

The most severe form of diabetic eye disease in both type 1 and type 2 diabetes is proliferative diabetic retinopathy (PDR). Neovascularization occurs when new blood vessels develop in the retina. These new fine blood arteries often leak through the epithelium and mold scar tissue. Tractional retinal detachment may result from scar tissue.2,3 The ETDRS classification system further divides proliferative diabetic retinopathy into its first, second, and third stages. Neovascularization of the Disc (NVD) or neovascularization elsewhere (NVE) is a sign of mild to moderate PDR. Conversely, high-risk PDR denotes NVD larger than about a third of the disc area, any NVD with vitreous hemorrhage or preretinal hemorrhage, and NVE larger than about half the circle area with vitreous hemorrhage or preretinal hemorrhage.3

Patients with inadequate or ineffective treatment often develop high-stage diabetic eye disease, which is a severe form of diabetic retinopathy that impairs vision. Hemorrhages preretinal, intragel, or both), tractional retinal detachment, and rubeosis iridis are all included in this pathological category.4,5

Focal or pan-retinal photocoagulation is the cornerstone of treatment for proliferative diabetic retinopathy. In a normal retina, 1200–1600 laser spots (approximately 500 m in size) are distributed or diffuse uniformly across the retina, not involving the macula, centrally obliterating the retinal pigment epithelium and external photoreceptors. Neovascularization of the outer retinal layer is rarely performed. Instead, the effect of the treatment is recalled as the elimination of pigment epithelial cells and the retinal tissue above them. The laser light is absorbed by the pigmented cells, and the resulting intensity destroys the outer retinal cells.5 The inner retinal areas that had been oxygen-depleted due to unfavorable perfusion of inward retinal arteries showed an improvement in oxygen supply after percutaneous panretinal photocoagulation (PRP).

The choriocapillaris (the vein supply to the cones, pigment epithelium, and rods) now becomes physically close to the internal retina, and there are not enough highly metabolically active rods and cones in the area of the consumes to hold oxygen from the choriocapillaris. Therefore, there is a decline in the number of viable hypoxic cells in the inner retina, which produce VEGF and other developmental factors. Due to the lack of VEGF production, the new vessels regress and may also disappear completely; however, adaptation of neovascularization without further growth is also possible. When neovascularization progresses despite laser treatment, it might cause vitreous hemorrhage or retinal detachment, and vitrectomy could be essential to maintain or improve vision.5

Rationale

Diabetic retinopathy is the primary cause of vision and visual deficiencies. The annual frequency of diabetic retinopathy went from 2.2% to 12.7%. The progression to proliferative diabetic retinopathy was higher in people with systemic illness than in those with no sickness.

Studies on aesthetic outcomes and patient satisfaction following PRP have been conducted. The concomitant increase in patients’ personal satisfaction following PRP is directly related to the advantageous effect of PRP on visual outcomes. Consequently, distinguishing the visual results and personal satisfaction after PRP in diabetic patients would result in a better prognostic image of the patient in general, subsequently expanding the achievement rates and viability of this treatment framework.

Accordingly, detailed examinations of all diabetic patients leading to the early detection of diabetic retinopathy changes and noting the progression of diabetic retinopathy based on the clinical profile of the patient will help in early intervention and maintain the visual outcome.

Aims and objectives

Aim: To study the clinical profile, visual outcome, and quality of life of patients undergoing pan-retinal photocoagulation for proliferative diabetic retinopathy.

Objectives:

  • • To study Clinical Profile of patients undergoing Pan Retinal Photocoagulation for PDR.

  • • To study Visual outcome of patients undergoing Pan Retinal Photocoagulation for PDR.

  • • To study Quality of life in patients undergoing Pan Retinal Photocoagulation for PDR.

Methods

Place of study: Outpatient Department of Ophthalmology, AVBRH, Sawangi (Meghe), Wardha.

Study design: An analytical observational prospective study.

Duration of study

This will be 2 years study for data collection from September 2022 to September 2024.

Participants

After considering the inclusion and exclusion criteria, diabetic patients hospitalized or registered at the Acharya Vinoba Bhave Rural Hospital were selected will be chosen for the study.

Inclusion criteria

  • • Patients having diabetes type 1 or diabetes type 2 having Proliferative diabetic retinopathy.

  • • Patients of age 40 years or above.

  • • Patients willing to undergo and fit for pan retinal Photocoagulation Procedure.

  • • Patients consenting to follow-up visits at 1, 6, and 1 year.

Exclusion criteria

  • • Patients with non-proliferative diabetic retinopathy (NPDR)/severe NPDR.

  • • Patients receiving additional ocular intervention such as intravitreal injection or cataract surgery.

  • • Patients with gestational diabetes.

  • • Patients with corneal opacities deleteriously affecting their visual acuity.

  • • Patient below age of 40 years.

Withdrawal criteria

  • • Subject withdrawal occurs when an individual decides to stop participating in the study, either during the screening or treatment phases.

  • • Any condition, including those listed under the convention’s avoidance measures or individual conditions, which, in the opinion of the specialist, expose the subject to significant risk.

  • • Any clinically significant adverse incident or substantial hostile event requires premature removal in the opinion of the physician.

  • • If a subject did not show up for their final scheduled appointment or the end of the study, they were lost to follow-up.

Ethical approval and informed consent

Ethical committee approval from the DMIHER was issued DMIMS (DU)/IEC/2022/201on 28 August 2022: (IEC No.- ECR/440/Inst/MH/2013/RR-2019). 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.

Patients will provide their consent after being briefed on the purpose of the study and any potential drawbacks. 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.

Confidentiality

Each participant will be given a unique number to use as a pseudonym during the evaluation and in any member-specific contact between the specialist and the support staff. The primary investigator will be responsible for maintaining the strict confidentiality of all enrollment files.

Sample size estimation

Sample size estimation was carried out using the following formula, taking into consideration the findings of Fu et al 2022 study

φ=πA(1−πB)πB(1−πA)
πDISCORDANT=πA(1−πB)+πB(1−πA)
npair≥(Z1−α/2(φ+1)+Z1−β(φ+1)2−(φ−1)2πDISCORDANT)(φ−1)2πDISCORDANT

Where,

α = 0.10;

β = 0.8;

Proportion before (πA) = 0.44;

Proportion after (πB) = 0.6739

Sample size = 57

Statistical analyses were performed using GraphPad Prism 7.0 version. Non-parametric data were analyzed using the chi-square test, and the Student’s unpaired t-test was used to analyze Parametric data. The level of significancewas set at p < 0.05.

Audit

The recorded data will be reviewed for quality by a supervisor once a month. The quality evaluator will have access to all clinical records, preliminary relevant documents and communications, and the archive of informed consent.

Data collection, tool and process

Detailed ocular examinations included best-corrected visual acuity on LogMAR (ETDRS chart), intraocular pressure measurement with automated tonometry, anterior segment evaluation using a slit-lamp, and fundus examination with direct ophthalmoscopy, indirect ophthalmoscopy, and a slit-lamp biomicroscopy setup with a +90D lens.

Procedure

Patients selected via the inclusion criteria set for the study will undergo the following procedure.

In accordance with the early treatment diabetic retinopathy study recommendations, PRP will be conducted with an automated pattern delivery system employing a spot size of 400–500 m on the retinal surface, 532 nm, 0.2 ms, 150–200 mW, and 1200–1500 spots split among three to four treatments.

Patients underwent a thorough eye examination (using indirect ophthalmoscopy) at one month, six months, and yearly checkups to record any changes or complications. Best-corrected visual acuity on LogMAR (ETDRS chart) will be recorded, and a +78D/90D slit-lamp lens will be used for the macula examination. At the start of the experiment and again at the end, patients were asked to fill out a quality-of-life questionnaire, the National Eye Institute Visual Function Questionnaire (NEI VFQ-25).

Pretrial and ancillary trial care

According to the protocol, all patients were reviewed until the end of the study period. In situations where the patient could not follow up, he or she communicated telephonically to review their status. In case of any adverse events, patients will be managed accordingly.

Dissemination

The findings from this study will be submitted to good impact factor journals.

Study status

The study is still recruiting the subjects and the patients are under review.

Expected outcomes

The prevalence of proliferative diabetic retinopathy is higher in patients aged 40 years or older than in those younger than 40 years.

Compared to alternative forms of treatment, pan-retinal photocoagulation significantly improves the quality of life and visual results of patients with proliferative diabetic retinopathy.

Scope

A study observing and analyzing the clinical characteristics, visual outcomes, and general well-being of proliferative diabetic retinopathy individuals undergoing pan-retinal photocoagulation.

Discussion

In this 2 year study, before and after undergoing pan-retinal photocoagulation, the clinical features, visual results, and quality of life of proliferative diabetic retinopathy patients before and after undergoing pan-retinal photocoagulation were assessed.

This research which was published by Rema M, et al.6 at 1 year follow-up, found 73% eyes that had good visual acuity (6/9) at baseline still had it; among the 53 eyes only 31 eyes had baseline visual acuity of 6/12-6/36 retained the same level of vision, while 18% (10 eyes) showed improvement. Twelve of the 17 eyes that had a baseline visual acuity of 6/60 maintained that level of clarity, while the vision of the other five improved. Twenty patients had vision loss due to vitreous hemorrhage (31.7%), nineteen had vision loss due to cataract progression (30%), fifteen had vision loss due to chronic macular edema (23.8%), six had vision loss due to macular preretinal hemorrhage (9.5%), and three had vision loss due to macular preretinal fibrosis (4.7%).

The likelihood of vision loss of at least five Early Treatment Diabetic Retinopathy Study (ETDRS) letters in treatment-naive PDR was found to be 50% 3.32 years after the first stabilization following PRP, as reported by Fu et al. 2022.7

Results from the National Eye Institute Visual Function Questionnaire (NEI VFQ-25), found by Vasilijevi JB et al. (2022),8 showed an improvement in patients’ vision from a baseline score of 65.4 17.4 to a post-PRP score of 63.3 19.5. Fewer laser burns were a significant predictor of a lower VFQ-25 composite score.

In our pilot study, we aimed to evaluate the clinical, visual, and quality-of-life profiles of patients with PDR.

Limitations

Small study population.

Short follow up period.

Probable implications

This analytical observational prospective study based on quality of life and visual outcome for patients undergoing pan-retinal photocoagulation for proliferative diabetic retinopathy would inform us about the prognostic value of pan-retinal photocoagulation for proliferative diabetic retinopathy.

Data availability

No data are associated with this article.

References

  • 1.  Eisma JH, Dulle JE, Fort PE: Current knowledge on diabetic retinopathy from human donor tissues. World J. Diabetes. 2015 Mar 15; 6(2): 312–320. PubMed Abstract | Publisher Full Text | Free Full Text
  • 2.  Romero-Aroca P, Baget-Bernaldiz M, Pareja-Rios A, et al.: Diabetic Macular Edema Pathophysiology: Vasogenic versus Inflammatory. J. Diabetes Res. 2016; 2016: 2156273.
  • 3.  Chaudhary, et al.: 2021 - Proliferative diabetic retinopathy (PDR).pdf.[cited 2023 Jul 29]. Reference Source
  • 4.  Kanski’s Clinical Ophthalmology - 9th Edition: [cited 2023 Jun 6]. Reference Source
  • 5.  Bressler N, Beck R, Ferris F: Panretinal Photocoagulation for Proliferative Diabetic Retinopathy. N. Engl. J. Med. 2011 Oct 20; 365: 1520–1526. Publisher Full Text
  • 6.  Vasilijević JB, Kovačević IM, Bukumirić ZM, et al.: Vision-Related Quality of Life and Treatment Satisfaction Following Panretinal Photocoagulation in Diabetic Retinopathy—A Panel Study. Medicina. 2022; 58(12): 1741. PubMed Abstract | Publisher Full Text | Free Full Text
  • 7.  Rema M, Sujatha P, Pradeepa R: Visual outcomes of pan-retinal photocoagulation in diabetic retinopathy at one-year follow-up and associated risk factors. Indian J. Ophthalmol. 2005; 53: 93–99. PubMed Abstract | Publisher Full Text
  • 8.  Fu DJ, Thottarath S, Faes L, et al.: Visual acuity outcome of stable proliferative diabetic retinopathy following initial complete panretinal photocoagulation. BMJ Open Ophthalmol. 2022 Sep 1; 7(1): e001068. Publisher Full Text

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Pandya M, Banait S and Daigavane S. Clinical profile, visual outcome and quality of life in patients undergoing pan retinal photocoagulation for proliferative diabetic retinopathy [version 1; peer review: 1 approved with reservations]. F1000Research 2024, 13:437 (https://doi.org/10.12688/f1000research.144879.1)
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Reviewer Report 22 Jul 2024
Youxin Chen, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China 
Approved with Reservations
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https://doi.org/10.5256/f1000research.158735.r277767
The article clearly outlines the study's objective, which is to investigate the impact of pan retinal photocoagulation (PRP) on the clinical characteristics, visual outcomes, and quality of life in patients with proliferative diabetic retinopathy (PDR). The study employs a prospective, ... Continue reading
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Chen Y. Reviewer Report For: Clinical profile, visual outcome and quality of life in patients undergoing pan retinal photocoagulation for proliferative diabetic retinopathy [version 1; peer review: 1 approved with reservations]. F1000Research 2024, 13:437 (https://doi.org/10.5256/f1000research.158735.r277767)
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https://f1000research.com/articles/13-437/v1#referee-response-277767
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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    Alongside their report, reviewers assign a status to the article:
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