NCT06908824

No Endotamponade for Macular Hole Repair: the NEMAR Study

The No Endotamponade for Macular Hole Repair (NEMAR) Study: An International Multi-center Randomized Controlled Trial Comparing Macular Hole Closure Using Internal Limiting Membrane Flap Without Endotamponade Versus Conventional Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 retrospective studies were encouraging. The purpose of this prospective international multi-centre randomised controlled 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.

Conditions

• Macular Hole
• Macular Hole Surgery

Interventions

Type	Name	Description
PROCEDURE	Conventional surgery	Pars plana vitrectomy (PPV) with temporal internal limiting membrane (ILM) flap would be performed. Perfluorocarbon liquid (PFCL) or viscoelastic may be used as an adjunct. Air/Fluid exchange would be performed at the end of surgery, further exchange of air with 8-14% octafluoropropane (C3F8) would be performed based on operating surgeon's discretion. In cases a temporal ILM flap could not be created, an ILM flap would be created from other quadrants, for example, a nasal ILM would be created instead. Patients with visually significant cataract may undergo concomitant phacoemulsification and intraocular lens implantation or deferred to post-operative month 6-12. Patients would be instructed to adopt a face-down posturing in the first 5 days following operation.
PROCEDURE	ILM flap with no gas tamponade	Pars plana vitrectomy with temporal internal limiting membrane (ILM) flap would be performed. The ILM flap would be stabilised over the macular hole using perfluorocarbon liquid (PFCL) followed by sub-PFCL dispersive viscoelastic injection. The PFCL would be removed towards the end of surgery. In cases a temporal ILM flap could not be created, an ILM flap would be created from other quadrants, for example, a nasal ILM would be created instead. Concomitant phacoemulsification and intraocular lens implantation would be performed in patients with visually significant cataract or deferred to post-operative month 6-12. Patients will be instructed to avoid excessive movement and adopt a face forward/ supine position for first 24 hours. Afterwards, there would be no restriction on post-operative posturing.

Timeline

• Start date: 2025-09-16
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-04-03
• Last updated: 2025-09-30

Locations

3 sites across 3 countries: Hong Kong, Poland, Taiwan