No Endotamponade for Macular Hole Repair: the NEMAR Study
Recruiting now · Not applicable
Conditions studied: Macular Hole, Macular Hole Surgery
In brief
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
Key facts
- Study ID
- NCT06908824
- Run by
- Chinese University of Hong Kong
- People needed
- 180
- Starts
- 2025-09-16
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-09-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Fellow eye enrolled in the study
- Eyes that underwent previous macular surgery
- Presence of maculopathy other than macular hole, epi-retinal membrane or myopic maculopathy. For example, age-related macular degeneration, diabetic macular edema or pre-existing macular scar
- Axial length >/= 28mm or presence of significant myopic chorio-retinal atrophy involving the fovea
- Minimum linear diameter >/=800µm
- Presence of contraindications to intraocular gas, such as advanced glaucoma or uncontrolled glaucoma
- Significant macular puckering (Govetto staging ≥ stage 2)
- Patients who are unable to give informed consent
- Patients who are pregnant
Where it is running
- Hong Kong Eye Hospital — Hong Kong, Hong Kong (enrolling)
- Poznan University of Medical Sicences, University Hospital in Poznan — Poznan, Poland
- Chang Gung Memorial Hospital — Taoyuan, Taiwan
Full record on ClinicalTrials.gov
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