A comparative study on clinical outcome of conventional trabeculectomy and glaucoma drainage device in a tertiary health care center

Ayushi Tayal; Sachin Daigavane

doi:10.12688/f1000research.140391.1

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Study Protocol

A comparative study on clinical outcome of conventional trabeculectomy and glaucoma drainage device in a tertiary health care center

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

Ayushi Tayal ¹, Sachin Daigavane¹

PUBLISHED 29 Aug 2023

Author details Author details

¹ Department of Ophthalmology, Jawaharlal nehru medical college, datta meghe institute of higher education and research., wardha, maharashtra, 442001, India

Ayushi Tayal
Roles: Conceptualization, Formal Analysis, Investigation, Methodology

Sachin Daigavane
Roles: Supervision, Validation, Visualization, 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: Glaucoma is becoming a more common cause of blindness as the world's population ages. Glaucoma, the second largest cause of blindness worldwide, accounts for approximately 15% of all blindness. However, it poses an even more significant public health concern than cataracts because the blindness it produces is irreversible. This study aims to compare the clinical outcomes of traditional trabeculectomy and glaucoma drainage devices. METHODOLOGY: This is a hospital-based study of 30 patients in which we compare clinical results after conventional trabeculectomy and implantation of a glaucoma drainage device. Intraocular pressure will be measured by an Applanation tonometer and best-corrected visual acuity testing will be performed in all patients. The data will be compared, and statistical analysis will be done. EXPECTED RESULTS: Patients with Glaucoma drainage implants will have better IOP control.

Keywords

Aurolab aqueous drainage implant, glaucoma surgery, refractory glaucoma, trabeculectomy, intraocular pressure.

Corresponding author: Ayushi Tayal

Competing interests: No competing interests were disclosed.

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

Copyright: © 2023 Tayal A and Daigavane S. 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: Tayal A and Daigavane S. A comparative study on clinical outcome of conventional trabeculectomy and glaucoma drainage device in a tertiary health care center [version 1; peer review: 1 approved with reservations]. F1000Research 2023, 12:1051 (https://doi.org/10.12688/f1000research.140391.1) First published: 29 Aug 2023, 12:1051 (https://doi.org/10.12688/f1000research.140391.1) Latest published: 29 Aug 2023, 12:1051 (https://doi.org/10.12688/f1000research.140391.1)

Introduction

High intraocular pressure (IOP), optic nerve deterioration, and visual impairments are the hallmarks of glaucoma, a condition that is a primary cause of blindness.¹ Glaucoma is a multifactorial optic neuropathy that manifests as classical optic nerve head characteristics and corresponding modifications in the visual field and accelerated ganglion cell ageing in the retina that in the presence or absence of any angle abnormalities, may or may not be connected to underlying disease cause.² Neovascular glaucoma, the secondary glaucoma brought on by uveitis, and angle recession are a few kinds of glaucoma that typically have poor responses to standard medical treatments and surgical methods.³^,⁴ Intraocular pressure (IOP) is the main focus of currently available standard treatments because it has been demonstrated that increased IOP causes the death of brain cells in glaucoma patients.⁵ Additionally, IOP is now thought to be the only risk factor for glaucoma that is practically adjustable and has benefits for maintaining the visual field (VF).

Uveitis is an inflammation and swelling of uvea, the central layer of the eye. In Europe and the United States, it causes 5% to 20% of blindness cases.⁶ Because it could be challenging to achieve a suitable IOP with medical interventions and procedures, uveitic glaucoma is challenging to control. Uveitic glaucoma is treated using a variety of methods. Trabeculectomy is one of the most frequently performed surgeries. The primary difficulty with this is fibrosis of bleb.⁷^,⁸ Although anti-fibrotic medications like mitomycin C have been applied during surgery, but the filtering surgery’s rate of success is still questionable.⁹

Compared to other refractory glaucoma, filtration surgery for uveitic glaucoma has lesser success rates due to the repeated inflammatory response of uveitis that occurs among patients.¹⁰ Aqueous drainage devices have become popular in recent years as glaucoma treatments. A preference for tube shunts that is increasing and trabeculectomy that is losing favour is also seen in surveys conducted by the American Glaucoma Society.¹¹

The increased usage of tube shunt surgery as a substitute to trabeculectomy is likely a result of concern over bleb-related problems like bleb leaks and bleb infections. The tube shunts when first developed, were often only used for glaucomas that had not responded to filtering surgery and were refractory. However, implantation of these devices in glaucomas with improved surgical prognosis has been motivated by a rising body of favourable experience with them. Refractory glaucoma is defined as uncontrolled intraocular pressure with evidence of deterioration in the optic nerve or visual field despite maximally tolerable anti-glaucoma medications (topical and/or systemic), previously unsuccessful non-seton surgical treatment, a combination of surgery and medications, or a high risk of failure for trabeculectomy.¹²

With untreated primary and refractory glaucomas, the current study compares the clinical outcomes of glaucoma drainage devices and traditional trabeculectomy in patients.

Aim and objectives

Aim

To research the effectiveness of traditional trabeculectomy and glaucoma drainage devices.

Objectives

1) To assess the clinical results of traditional trabeculectomy in glaucoma patients with uncontrolled primary glaucoma.
2) To assess the clinical results of traditional trabeculectomy in glaucoma patients who have refractory glaucoma.
3) To evaluate the clinical results of drainage devices in patients with uncontrolled primary glaucoma.
4) To evaluate the effectiveness of glaucoma drainage devices in people with refractory glaucoma.
5) To compare the treatment results of traditional trabeculectomy with glaucoma drainage devices in patients with uncontrolled primary glaucoma.
6) To compare the therapeutic results of traditional trabeculectomy and glaucoma drainage devices in glaucoma patients who have not responded to other treatments.

Trial design - Single Centric, hospital based cross sectional study.

Protocol

This is a hospital-based study in which subjects would be recruited from the OPD of ophthalmology at Acharya Vinobha Bhave Rural Hospital Sawangi, Meghe, Wardha, Maharashtra, with clearance from the institutional ethical committee of Datta Meghe institute of higher education and research and will adhere to the principles of the Helsinki Declaration. The specifics of the surgery will be properly explained to each patient. The study will gradually recruit the patients who meet the inclusion criteria. This study will be carried out under standard preoperative, intraoperative and post operative conditions by a single experienced surgeon. Study participants will be divided into two groups. Group-A (Trabeculectomy group) and Group-B (Glaucoma Drainage Device group) taking into consideration factors such as staphyloma, scleral thinning and high myopia, participants with this pathology will be undergoing glaucoma drainage device implantation. Subjects will be invited & screened for inclusion and exclusion criteria for selection. All patients in both groups will be followed up on a monthly basis for the next two years. At each follow-up, we evaluate IOP, visual acuity and need of anti-glaucoma medications in post-operative patients, and both groups are compared.

Inclusion criteria

1) Patients with uncontrolled primary glaucoma.
2) Patients who will be diagnosed as secondary glaucoma.
3) Patients who will be diagnosed as refractory glaucoma.
4) Patients consenting to study/giving valid consent.

Exclusion criteria

1) Patients with any ocular infection.
2) Patients having corneal decompensation.
3) Patients with neovascular glaucoma.
4) Patients who did not successfully complete a minimum 1-year follow-up period were not included in this study.

Interventions

There will be a clinical history gathered and best corrected visual acuity (Snellen’s chart), slit lamp examination, Intra Ocular Pressure measurement (applanation tonometer), fundoscopy (slit lamp biomicroscopy with 90 D, direct, and indirect ophthalmoscopy with 20 D) and gonioscopy are all included in a thorough ophthalmic checkup. OCT-RNFL and Perimetry will be done. Patients who underwent trabeculectomy and glaucoma drainage device surgery (Aurolab aqueous drainage implant) will be included in the study.

The conventional trabeculectomy surgical technique

A conjunctival flap precisely fornix based will be made, and the corneal traction suture will be positioned at the 12 o’clock position. Gentle diathermy will be used to cauterise the blood vessels. A rectangular scleral flap of 4×3 mm with partial thickness will be made and a trab of 0.8×2.0 mm will be achieved followed by a Peripheral Iridectomy. A single 10-0 nylon suture will be given to secure the scleral flap, with possible extra sutures in between the sutures and at the flap’s corners. The conjunctiva at the limbus will be stitched up with a 10-0 nylon suture.

Glaucoma drainage device (AADI) surgical method

Tenon’s tissue will be dissected after a conjunctival flap (fornix based). The operating surgeon will choose the implant insertion site depending on the amount of conjunctival scarring, if any, and whether it will be supero-temporal or infero-nasal. Using muscle hooks, adjoining recti muscles in the desired quadrant will be isolated. After that, the AADI implant will be prepped to look for possible manufacturing flaws. The end plate will then be positioned so that the front edge of the plate will be roughly 8 mm away from the limbus, in between the neighbouring recti muscles. After that, 9-0 Nylon sutures will be used to secure the plate to the underlying sclera by passing them through the implant’s fixation holes. The tube’s connection to the sclera will be stabilised using a non-compressing mattress suture. By tying it with a 6-0 vicryl suture, temporary tube occlusion will be accomplished. A 23-gauge needle will be used to produce a scleral fistula at a distance of roughly 3 mm from the limbus. In order for the tube to lie 1-2 mm past the surgical limbus, it will then be anteriorly bevelled up and introduced into the AC through the scleral tract. The operating surgeon will directly observe the tube to ensure its place. Fenestrations in the tube will be constructed, necessitating short-term IOP management in the immediate postoperative period until the vicryl suture lyses. After that, 8-0 Vicryl sutures will be used to close the conjunctiva and tenon’s capsule using both interrupted and running procedures.

Outcomes measure

Primary outcome measures

1) Visual acuity testing by Snellen’s chart:
It is used to assess distant visual acuity. The patient is seated 6m away from the Snellen’s chart and is instructed to read the chart with both eyes, one after the other. When the patient can read up to a 6 m line, his visual acuity is reported as 6/6, and depending on the smallest line that the patient can read from a 6 m distance, his vision is recorded as 6/9, 6/12, 6/18, 6/24, 6/36, and 6/60.
2) Intra Ocular Pressure measurement by applanation tonometry:
The Goldmann Applanation Tonometer is commonly recognized as the gold standard in intraocular pressure (IOP) measurement. A topical anesthetic is instilled into the conjunctival sac, followed by a fluorescein stain. The cobalt blue filter reveals a pattern of two green semicircular mires, with the inner borders of semicircles aligned. The IOP is calculated by multiplying the dial value by ten in mmHg.

Secondary outcome measures

1) Moorfields bleb grading (Figure 1):
The bleb is assessed and characterized with respect to:
- • Diffusion area
- • Height
- • Vascularity in central, peripheral bleb area and non-bleb area.
2) Need of anti-glaucoma medication:
If the post-operative IOP measurement indicates greater values, we will administer anti-glaucoma drugs later.
3) OCT-RNFL and Humphrey visual field analysis.

Figure 1. Moorfields bleb grading system.

Sampling procedure

Using sample size formula with desired error of margin

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

Where Zα/2 is the level of significance at 5% i.e.:

99.5% confidence interval = 2.8

P = Prevalence of secondary glaucoma = 0.50% i.e. 0.005

d = Desired error of margin = 5% = 0.05

n = \frac{{(2.8)}^{2} \times 0.005 \times (1 - 0.005)}{{(0.05)}^{2}}

n = 14.8

n = 15 patient needed in each group.

Total sample size = 30

Study reference: Arun Narayanaswamy et al.¹³

Formula reference: Daniel et al.¹⁴

Sample size: After meeting the inclusion and exclusion requirements, a total of 30 SUBJECTS will be registered in this interventional cross-sectional hospital-based study.

Statistical analysis

This will be done with the aid of descriptive and inferential statistics, chi-square tests, odds ratios, and software analysis with the SPSS-24.0 system and Graph Pad prism 7.0 version and p < 0.05 is considered as level of significance.

Dissemination

We plan to publish in an indexed journal and present the study in national conference proceedings.

Study status

The recruitment of participants has been started.

Discussion

In this study, we compared the clinical outcomes of glaucoma drainage tube implantation to traditional trabeculectomy. The most frequent etiology of vision loss and blindness is glaucoma. In India, it is the second most frequent reason for blindness, and the majority of people are unaware of the cure. There has been very little study in this field to evaluate the efficiency of glaucoma drainage devices and routine trabeculectomy. As a result, we intend to compare the therapeutic effects of glaucoma drainage devices and conventional trabeculectomy in AVBRH patients with uncontrolled primary and refractory glaucoma.

A detailed analysis of GDDs revealed that the Baerveldt and Ahmed implants’ respective IOP changes were roughly 54 and 51%.¹⁵ After a year, Harbick et al. discovered a considerable net decline in visual acuity, which they attributed to concurrent pre-existing retinal and corneal problems.¹⁶ Patients who underwent tube shunt surgery versus those who underwent trabeculectomy with MMC during the first three years of follow-up were more likely to maintain IOP control and avoid persistent hypotonia, or reoperation for glaucoma.¹⁷

According to Joshi et al., glaucoma drainage implants have become an essential surgical option for treating secondary glaucoma. Although these implants were previously utilised solely after a failed trabeculectomy, they are now increasingly being employed as a main surgical technique in cases of uveitic glaucoma.¹⁸

In 10 patient’s 14 eyes with uveitic glaucoma associated with Behcet’s disease, Satana et al. reported that AGV implantation led to 90.9% success rates after 18 months and 72.7% success rates after 2 years.¹⁹ Retrospective investigation of uveitic glaucoma patients 60 eyes who underwent AGV implantation indicated success rates of 77.0% after one year and 50.0% after four years (IOP range of 5 to 21 mmHg and a 25.0% decrease in IOP from before surgery.²⁰ Preoperative corticosteroid usage may increase AGV surgical outcome in uveitic glaucoma. Preoperative prednisone at 1 mg/kg/day was indicated by Mata et al. until the inflammation was controlled. Oral corticosteroids are decreased during a four-week period following surgery.²¹

In eyes with chronic inflammatory glaucoma, N. Bhardwaj, S. M. Iverson, W. Shi, and colleagues found that implantation of the Baerveldt Glaucoma Drainage Device was more likely to maintain IOP control and prevent glaucoma reoperation than trabeculectomy with antifibrotic therapy.²²

Ethical considerations

Institutional Ethical Clearance has been obtained on 29/8/2022

IEC No – DMIMS (DU)/IEC/2022/198

CTRI Registration was done on 26/07/2023

CTRI Number – REF/2023/07/070943

Data availability

No data as this is a study protocol.

Acknowledgements

I would like to acknowledge Mr Laxmikant Umate Sir, who has helped me in sample size calculation and data analysis planning.

References

1. Baneke AJ, Lim KS, Stanford M: The pathogenesis of raised intraocular pressure in uveitis. Curr. Eye Res. 2016; 41(2): 137–149. Publisher Full Text
2. Burr J, Azuara-Blanco A, Avenell A, et al.: Medical versus surgical interventions for open angle glaucoma. Cochrane Database Syst. Rev. 2012; 9: CD004399. Publisher Full Text
3. Wiese C, Heiligenhaus A, Heinz C: Changes in inflammatory activity after glaucoma filtration surgery in children with chronic anterior uveitis. Ocul. Immunol. Inflamm. 2016; 24(4): 397–401. PubMed Abstract | Publisher Full Text
4. Eksioglu U, Yakin M, Sungur G, et al.: Short- to long-term results of Ahmed glaucoma valve in the management of elevated intraocular pressure in patients with pediatric uveitis. Can. J. Ophthalmol. 2017; 52(3): 295–301. PubMed Abstract | Publisher Full Text
5. Dreyer EB, Lipton SA: New perspectives on glaucoma. JAMA. 1999; 281(4): 306–308. Comment in: JAMA. 1999;281(23):2186-7. Publisher Full Text
6. Amoozgar B, Lin SC, Han Y, et al.: A role for antimetabolites in glaucoma tube surgery: current evidence and future directions. Curr. Opin. Ophthalmol. 2016; 27(2): 164–169. PubMed Abstract | Publisher Full Text
7. Schoenberg ED, Blake DA, Swann FB, et al.: Effect of two novel sustained-release drug delivery systems on bleb fibrosis: an in vivo glaucoma drainage device study in a rabbit model. Transl. Vis. Sci. Technol. 2015; 4(3): 4. PubMed Abstract | Publisher Full Text | Free Full Text
8. Medeiros Pinto J, Pinto Ferreira N, Abegao PL: Ahmed valve upstream obstruction caused by fibrous ingrowth: surgical approach. J. Glaucoma. 2017; 26(1): e236–e238. PubMed Abstract | Publisher Full Text
9. Yazdani S, Mahboobipour H, Pakravan M, et al.: Adjunctive mitomycin C or amniotic membrane transplantation for Ahmed glaucoma valve implantation: a randomized clinical trial. J. Glaucoma. 2016; 25(5): 415–421. Publisher Full Text
10. Kalinina Ayuso V, Scheerlinck LM, de Boer JH : The effect of an Ahmed glaucoma valve implant on corneal endothelial cell density in children with glaucoma secondary to uveitis. Am J. Ophthalmol. 2013; 155(3): 530–535. PubMed Abstract | Publisher Full Text
11. Joshi AB, Parrish RK, Feuer WF: 2002 Survey of the American Glaucoma Society. Practice preferences for glaucoma surgery and antifibrotic use. J. Glaucoma. 2005; 14: 172–174. PubMed Abstract | Publisher Full Text
12. Nassiri N, Kamali G, Rahnavardi M, et al.: Ahmed glaucoma valve and single-plate Molteno implants in treatment of refractory glaucoma: a comparative study. Am J. Ophthalmol. 2010; 149(6): 893–902. PubMed Abstract | Publisher Full Text
13. Narayanaswamy A, Baskaran M, Zheng Y, et al.: The prevalence and types of glaucoma in an urban Indian population: the Singapore Indian Eye Study. Invest. Ophthalmol. Vis. Sci. 2013; 54(7): 4621–4627. Publisher Full Text
14. Daniel WW: Biostatistics: A Foundation for Analysis in the Health Sciences. 7th ed.New York: John Wiley & Sons; 1999.
15. Hong CH, Arosemena A, Zurakowski D, et al.: Glaucoma drainage devices: A systematic literature review and current controversies. Surv. Ophthalmol. 2005; 50: 48–60. PubMed Abstract | Publisher Full Text
16. Harbick KH, Sidoti PA, Budenz DL, et al.: Outcomes of inferonasal Baerveldt glaucoma drainage implant surgery. J. Glaucoma. 2006; 15: 7–12. PubMed Abstract | Publisher Full Text
17. Gedde SJ, Schiffman JC, Feuer WJ, et al.: The Tube Versus Trabeculectomy Study was followed up on after three years. Am J. Ophthalmol. 2009 Aug 10; 148: 670–684. PubMed Abstract | Publisher Full Text
18. Joshi AB, Parrish RK 2nd, Feuer WF: 2002 survey of the American Glaucoma Society: practice preferences for glaucoma surgery and antifibrotic use. J. Glaucoma. 2005; 14: 172–174. PubMed Abstract | Publisher Full Text
19. Satana B, Yalvac IS, Sungur G, et al.: Ahmed glaucoma valve implantation for uveitic glaucoma secondary to Behcet disease. J. Glaucoma. 2015; 24(8): 607–612. PubMed Abstract | Publisher Full Text
20. Costa VP, Azuara-Blanco A, Netland PA, et al.: Efficacy and safety of adjunctive mitomycin C during Ahmed glaucoma valve implantation: a prospective randomized clinical trial. Ophthalmology. 2004; 111(6): 1071–1076. PubMed Abstract | Publisher Full Text
21. Mata AD, Burk SE, Netland PA, et al.: Management of uveitic glaucoma with Ahmed glaucoma valve implantation. Ophthalmology. 1999; 106(11): 2168–2172. PubMed Abstract | Publisher Full Text
22. Iverson SM, Bhardwaj N, Shi W, et al.: Surgical outcomes of inflammatory glaucoma: a comparison of trabeculectomy and glaucoma-drainage-device implantation. Jpn. J. Ophthalmol. 2015; 59(3): 179–186. Publisher Full Text

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VERSION 1 PUBLISHED 29 Aug 2023

Author details Author details

¹ Department of Ophthalmology, Jawaharlal nehru medical college, datta meghe institute of higher education and research., wardha, maharashtra, 442001, India

Ayushi Tayal
Roles: Conceptualization, Formal Analysis, Investigation, Methodology

Sachin Daigavane
Roles: Supervision, Validation, Visualization, 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: 29 Aug 2023, 12:1051

https://doi.org/10.12688/f1000research.140391.1

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© 2023 Tayal A and Daigavane S. 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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Tayal A and Daigavane S. A comparative study on clinical outcome of conventional trabeculectomy and glaucoma drainage device in a tertiary health care center [version 1; peer review: 1 approved with reservations]. F1000Research 2023, 12:1051 (https://doi.org/10.12688/f1000research.140391.1)

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Reviewer Report 14 Nov 2023

Nader Bayoumi, Department of Ophthalmology, Faculty of Medicine, Alexandria University, Alexandria, Alexandria Governorate, Egypt

Approved with Reservations

https://doi.org/10.5256/f1000research.153736.r220712

The manuscript needs thorough English language revision.

Introduction

High intraocular pressure (IOP), optic nerve deterioration, and visual impairments are the hallmarks of glaucoma” The hallmark of glaucoma is optic nerve affection with subsequent

The manuscript needs thorough English language revision.

Introduction

High intraocular pressure (IOP), optic nerve deterioration, and visual impairments are the hallmarks of glaucoma” The hallmark of glaucoma is optic nerve affection with subsequent visual field deterioration. IOP is an important factor, but not the first of the hallmarks of glaucoma. Please rephrase to reflect this concept.
Increased IOP causes the death of brain cells in glaucoma patients” Please modify to “death of retinal ganglion cells”.
A preference for tube shunts that is increasing and trabeculectomy that is losing favour” Please specify to the reader whether the authors are referring to “primary” or “repeat / subsequent” interventions for glaucoma.

Aim and Objectives

Please unify the terminology used for the study participants (“patients, people”)
Please specify the objectives of “clinical results” (do the authors refer to efficacy, or safety?).
Please present the objectives in concise statements avoiding undue repetition. All 6 objectives proposed apparently fit into “comparison of trabeculectomy to GDDs in primary and refractory glaucoma”.

Protocol

Please mention the Country of the study setting(s).
Gradually recruit” Do the patients refer to “sequential recruitment”? Please rephrase.
Please mention the method of randomisation if this study is randomised.
Taking into consideration factors such as staphyloma, scleral thinning and high myopia,” Do the authors imply that eyes with these conditions will undergo GDDs without randomisation? This would represent a significant sampling bias to the study and would confound the results.
Please mention clearly whether the study eyes (especially in the GDDs group) will be treatment-naïve or would have been subjected to prior glaucoma surgery.

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?

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

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Glaucoma

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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14 Nov 2023 | for Version 1

Nader Bayoumi, Department of Ophthalmology, Faculty of Medicine, Alexandria University, Alexandria, Alexandria Governorate, Egypt

6 Views Cite this report Responses(0)

Approved With Reservations

The manuscript needs thorough English language revision.

Introduction

High intraocular pressure (IOP), optic nerve deterioration, and visual impairments are the hallmarks of glaucoma” The hallmark of glaucoma is optic nerve affection with subsequent visual field deterioration. IOP is an important factor, but not the first of the hallmarks of glaucoma. Please rephrase to reflect this concept.
Increased IOP causes the death of brain cells in glaucoma patients” Please modify to “death of retinal ganglion cells”.
A preference for tube shunts that is increasing and trabeculectomy that is losing favour” Please specify to the reader whether the authors are referring to “primary” or “repeat / subsequent” interventions for glaucoma.

Aim and Objectives

Please unify the terminology used for the study participants (“patients, people”)
Please specify the objectives of “clinical results” (do the authors refer to efficacy, or safety?).
Please present the objectives in concise statements avoiding undue repetition. All 6 objectives proposed apparently fit into “comparison of trabeculectomy to GDDs in primary and refractory glaucoma”.

Protocol

Please mention the Country of the study setting(s).
Gradually recruit” Do the patients refer to “sequential recruitment”? Please rephrase.
Please mention the method of randomisation if this study is randomised.
Taking into consideration factors such as staphyloma, scleral thinning and high myopia,” Do the authors imply that eyes with these conditions will undergo GDDs without randomisation? This would represent a significant sampling bias to the study and would confound the results.
Please mention clearly whether the study eyes (especially in the GDDs group) will be treatment-naïve or would have been subjected to prior glaucoma surgery.

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?

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

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Glaucoma

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

Responses (0)

[1] 1. Baneke AJ, Lim KS, Stanford M: The pathogenesis of raised intraocular pressure in uveitis. Curr. Eye Res. 2016; 41(2): 137–149. Publisher Full Text

[2] 2. Burr J, Azuara-Blanco A, Avenell A, et al.: Medical versus surgical interventions for open angle glaucoma. Cochrane Database Syst. Rev. 2012; 9: CD004399. Publisher Full Text

[3] 3. Wiese C, Heiligenhaus A, Heinz C: Changes in inflammatory activity after glaucoma filtration surgery in children with chronic anterior uveitis. Ocul. Immunol. Inflamm. 2016; 24(4): 397–401. PubMed Abstract | Publisher Full Text

[4] 4. Eksioglu U, Yakin M, Sungur G, et al.: Short- to long-term results of Ahmed glaucoma valve in the management of elevated intraocular pressure in patients with pediatric uveitis. Can. J. Ophthalmol. 2017; 52(3): 295–301. PubMed Abstract | Publisher Full Text

[5] 5. Dreyer EB, Lipton SA: New perspectives on glaucoma. JAMA. 1999; 281(4): 306–308. Comment in: JAMA. 1999;281(23):2186-7. Publisher Full Text

[6] 6. Amoozgar B, Lin SC, Han Y, et al.: A role for antimetabolites in glaucoma tube surgery: current evidence and future directions. Curr. Opin. Ophthalmol. 2016; 27(2): 164–169. PubMed Abstract | Publisher Full Text

[7] 7. Schoenberg ED, Blake DA, Swann FB, et al.: Effect of two novel sustained-release drug delivery systems on bleb fibrosis: an in vivo glaucoma drainage device study in a rabbit model. Transl. Vis. Sci. Technol. 2015; 4(3): 4. PubMed Abstract | Publisher Full Text | Free Full Text

[8] 8. Medeiros Pinto J, Pinto Ferreira N, Abegao PL: Ahmed valve upstream obstruction caused by fibrous ingrowth: surgical approach. J. Glaucoma. 2017; 26(1): e236–e238. PubMed Abstract | Publisher Full Text

[9] 9. Yazdani S, Mahboobipour H, Pakravan M, et al.: Adjunctive mitomycin C or amniotic membrane transplantation for Ahmed glaucoma valve implantation: a randomized clinical trial. J. Glaucoma. 2016; 25(5): 415–421. Publisher Full Text

[10] 10. Kalinina Ayuso V, Scheerlinck LM, de Boer JH : The effect of an Ahmed glaucoma valve implant on corneal endothelial cell density in children with glaucoma secondary to uveitis. Am J. Ophthalmol. 2013; 155(3): 530–535. PubMed Abstract | Publisher Full Text

[11] 11. Joshi AB, Parrish RK, Feuer WF: 2002 Survey of the American Glaucoma Society. Practice preferences for glaucoma surgery and antifibrotic use. J. Glaucoma. 2005; 14: 172–174. PubMed Abstract | Publisher Full Text

[12] 12. Nassiri N, Kamali G, Rahnavardi M, et al.: Ahmed glaucoma valve and single-plate Molteno implants in treatment of refractory glaucoma: a comparative study. Am J. Ophthalmol. 2010; 149(6): 893–902. PubMed Abstract | Publisher Full Text

[13] 13. Narayanaswamy A, Baskaran M, Zheng Y, et al.: The prevalence and types of glaucoma in an urban Indian population: the Singapore Indian Eye Study. Invest. Ophthalmol. Vis. Sci. 2013; 54(7): 4621–4627. Publisher Full Text

[14] 14. Daniel WW: Biostatistics: A Foundation for Analysis in the Health Sciences. 7th ed.New York: John Wiley & Sons; 1999.

[15] 15. Hong CH, Arosemena A, Zurakowski D, et al.: Glaucoma drainage devices: A systematic literature review and current controversies. Surv. Ophthalmol. 2005; 50: 48–60. PubMed Abstract | Publisher Full Text

[16] 16. Harbick KH, Sidoti PA, Budenz DL, et al.: Outcomes of inferonasal Baerveldt glaucoma drainage implant surgery. J. Glaucoma. 2006; 15: 7–12. PubMed Abstract | Publisher Full Text

[17] 17. Gedde SJ, Schiffman JC, Feuer WJ, et al.: The Tube Versus Trabeculectomy Study was followed up on after three years. Am J. Ophthalmol. 2009 Aug 10; 148: 670–684. PubMed Abstract | Publisher Full Text

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A comparative study on clinical outcome of conventional trabeculectomy and glaucoma drainage device in a tertiary health care center

Abstract

Keywords

Introduction

Aim and objectives

Aim

Objectives

Protocol

Inclusion criteria

Exclusion criteria

Interventions

The conventional trabeculectomy surgical technique

Glaucoma drainage device (AADI) surgical method

Outcomes measure

Figure 1. Moorfields bleb grading system.

Sampling procedure

Statistical analysis

Dissemination

Study status

Discussion

Ethical considerations

Data availability

Acknowledgements

References

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