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
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>= 18 years

• Presence of full thickness macular hole in one eye (defined as full thickness discontinuity of neuro-sensory retina at the macula on optical coherence tomography)

• Able to comply to post-operative posture

• VA ≥0.05 and ≤0.8

Locations
Other Locations
Hong Kong Special Administrative Region
Hong Kong Eye Hospital
RECRUITING
Hong Kong
Poland
Poznan University of Medical Sicences, University Hospital in Poznan
NOT_YET_RECRUITING
Poznan
Taiwan
Chang Gung Memorial Hospital
NOT_YET_RECRUITING
Taoyuan District
Contact Information
Primary
Simon KH Dr Szeto, MBChB, MSc, FRCOphth
simonkhszeto@cuhk.edu.hk
852 39435886
Time Frame
Start Date: 2025-09-16
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 180
Treatments
Active_comparator: Conventional surgery
Patients would undergo conventional surgery to repair macular hole and be instructed to adopt a face-down posturing in the first 5 days following operation.
Experimental: Internal limiting membrane (ILM) flap with no gas tamponade
Patients would undergo macular hole repair by the ILM flap with no gas tamponade technique. Patients will be instructed to avoid excessive movement and adopt a sit up/supine posture for the first 24 hours, beyond which there will be no posturing restriction.
Related Therapeutic Areas
Sponsors
Collaborators: Chang Gung University, Poznan University of Medical Sciences
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov