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No Endotamponade for Macular Hole Repair: the NEMAR Study

RecruitingNAAges 18 Years - anyAllChinese University of Hong Kong
NCT06908824 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Conventional surgery
  • ILM flap with no gas tamponade
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Where

3 sites
Hong Kong Eye Hospital
Hong Kong, Hong Kong
Poznan University of Medical Sicences, University Hospital in Poznan
Poznan, Poland
Chang Gung Memorial Hospital
Taoyuan, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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