No Endotamponade for Macular Hole Repair: the NEMAR Study

Not Applicable

Not yet recruiting

• Conditions: Macular Hole; Macular Hole Surgery

• Registration Number: NCT06908824
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Full-thickness macular hole (MH) is a common sight threatening macular condition with a prevalence of 3.3 per 1000 individuals. Prompt surgical repair of MH is imperative in preventing irreversible vision loss from MH as the majority of patients would experience progressive loss of central vision, often resulting in visual acuity (VA) of 20/200 or worse and the spontaneous closure rate is less than 10%.

Pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling (with or without ILM flap) and gas tamponade, herein referred to as conventional surgery, is the current standard-of-care surgical technique in repairing MH.

Recently, a novel surgical technique that omits the need of gas tamponade to repair MH has been proposed, early results from two interventional case series were encouraging.

These encouraging findings highlight the need for further evaluation of the effectiveness of this novel surgical technique. Therefore, we have conducted a retrospective comparative study to assess the effectiveness and safety of the ILM flap with no endotamponade technique in relation to conventional surgery with gas tamponade.

The purpose of this study is to compare the efficacy and safety of two surgical techniques in treating MH:

1. Conventional surgery: PPV with ILM peeling and gas or silicone oil tamponade

2. ILM flap with no gas tamponade surgery: PPV with ILM flap with no gas tamponade

Detailed Description

MH is a common macular condition that requires prompt surgical intervention to prevent irreversible vision loss. Conventional surgical repair of MH involves PPV, ILM peeling and gas tamponade followed by post-operative face down posturing. The use of gas tamponade, however, is associated with impairment of vision in the early post-operative period and restriction of air travel. Moreover, fluorinated ophthalmic gases are potent green house gases that contribute to global warming.

Recently, a novel surgical technique to repair MH without endotamponade has been proposed, termed the ILM flap with no gas tamponade technique.

There is currently no published randomised controlled trial comparing the efficacy and safety of MH repair using conventional surgical technique and the ILM flap with no gas tamponade technique.

Patients with confirmed full thickness MH on optical coherence tomography will be screened and invited to join the study. Written informed consent will be obtained. Baseline screening will be performed.

Recruited study participants will be randomly allocated to one of the two study groups:

1. Conventional surgery: Participants will undergo PPV, ILM peeling and gas tamponade to repair the MH. They would be instructed to adopt a face down posture for at least 5 days post-operatively.

2. ILM flap with no gas tamponade surgery: Participants will undergo PPV, ILM flap. No gas tampons would be required and there would be no restriction on post-operative posturing.

Participants will be instructed to attend post-operative follow up visits to undergo routine clinical examination, visual acuity checking and retinal imaging performed.

Study Timeline

• Study First Submitted: 2025-03-24
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-01
• Study First Posted: 2025-04-03
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Study Start: 2025-07-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age >= 18 years
• Presence of full thickness macular hole in one eye (defined as full thickness discontinuity of euro-sensory retina at the macula on optical coherence tomography)
• Able to comply to post-operative posture

Exclusion Criteria

• Fellow eye enrolled in the study
• Eyes that underwent previous macular surgery
• Presence of maculopathy other than macular hole, api-retinal membrane or myopic maculopathy. For example, age-related macular degeneration, diabetic macular edema or pre-existing macular scar
• Axial length >/= 30mm or presence of significant myopic chorio-retinal atrophy involving the fovea
• Minimum linear diameter >/=1000µm
• Presence of contraindications to intraocular gas, such as advanced glaucoma or uncontrolled glaucoma
• Patients who are unable to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Macular hole closure rate	3 months	The primary outcome is the rate of macular hole closure at post-operative month 3 between the two intervention groups.; Closure of macular hole is defined as the presence of continuous retinal tissue over the retinal pigment epithelium (RPE) without bare RPE exposed to vitreous cavity on optical coherence tomography (OCT).

Secondary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity (BCVA) in the study eye	12 months	Best corrected visual acuity will be checked using the Snellen visual acuity chart
Pattern of macular hole closure	12 months	The pattern of macular hole closure will be assessed on optical coherence tomography
Rate of foveal gliosis	12 months	Based on optical coherence tomography.
Retinal sensitivity	12 months	Microperimetry will be performed to assess the retinal sensitivity
Patients reported visual function	12 months	The patient reported visual function will be assessed using the National Eye Institute 25-item visual function questionnaire (NEI VFQ-25).; The score ranges from 0-100, with higher score indicating better visual function.
Vision Preference Value Scale	12 months	Using a previously validated questionnaire to determine vision preference value and treatment preferences.; Preference values were graded on a scale from 0 to 1, with 0 indicating death and 1 indicating perfect health with perfect vision.
Metamorphosis score	12 months	Using M-CHARTS (Inami \& Co., Ltd., Tokyo, Japan) Ranges from 0-10. 0 indicates no metamorphopsia and 10 indicates severe metamorphopsia.

Trial Locations

Locations (1)

Hong Kong Eye Hospital; 🇭🇰 Hong Kong, Hong Kong