No Endotamponade for Macular Hole Repair: the NEMAR Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Conventional surgery
- ILM flap with no gas tamponade
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
Chinese University of Hong Kong
Lead sponsor
Poznan University of Medical Sciences
Collaborator
Chang Gung University
Collaborator
Source ClinicalTrials.gov