Clinical trial NCT06908824: No Endotamponade for Macular Hole Repair: the NEMAR Study
Official title: The No Endotamponade for Macular Hole Repair (NEMAR) Study:
        A Randomized Controlled Trial Comparing Macular Hole Closure Using Internal Limiting Membrane Flap Without Endotamponade Versus Conventional Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Macular Hole
Macular Hole Surgery
Keywords: Macular Hole
Vitrectomy
Macular surgery
Internal limiting membrane peeling
Gas tamponade
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Macular hole closure rate
timeFrame: 3 months
Secondary outcomes:
measure: Best Corrected Visual Acuity (BCVA) in the study eye
timeFrame: 12 months
measure: Pattern of macular hole closure
timeFrame: 12 months
measure: Rate of foveal gliosis
timeFrame: 12 months
measure: Retinal sensitivity
timeFrame: 12 months
measure: Patients reported visual function
timeFrame: 12 months
measure: Vision Preference Value Scale
timeFrame: 12 months
measure: Metamorphosis score
timeFrame: 12 months
Other outcomes:
measure: Number of participants with surgery related adverse events
timeFrame: 12 months
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Eye Hospital
Study officials:
affiliation: Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong
name: Simon KH Szeto, FCOphth(HK)
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Linz MO, Bressler NM, Chaikitmongkol V, Sivaprasad S, Patikulsila D, Choovuthayakorn J, Watanachai N, Kunavisarut P, Menon D, Tadarati M, Delalibera Pacheco K, Sanyal A, Scott AW. Vision Preference Value Scale and Patient Preferences in Choosing Therapy for Symptomatic Vitreomacular Interface Abnormality. JAMA Ophthalmol. 2018 Jun 1;136(6):658-664. doi: 10.1001/jamaophthalmol.2018.1272.
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citation: Stopa M, Ciesielski M, Rakowicz P. Macular Hole Closure Without Endotamponade Application. Retina. 2023 Apr 1;43(4):688-691. doi: 10.1097/IAE.0000000000002850. Epub 2020 May 25.
citation: Szeto SKH, Yu AHY, Tsang CW, Mohamed S, Chen LJ, Lai TYY. COMPLEX MACULAR HOLE CLOSURE BY TEMPORAL INTERNAL LIMITING MEMBRANE FLAP WITHOUT ENDOTAMPONADE. Retina. 2024 Nov 1;44(11):1915-1922. doi: 10.1097/IAE.0000000000004201.