NCT06908824 No Endotamponade for Macular Hole Repair: the NEMAR Study
| NCT ID | NCT06908824 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Macular Hole |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-09-16 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2025-09-16 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Simon KH Szeto, MBChB, FRCOphth
PRINCIPAL INVESTIGATOR
Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06908824 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Macular Hole. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06908824 currently recruiting?
Yes, NCT06908824 is actively recruiting participants. Contact the research team at simonkhszeto@cuhk.edu.hk for enrollment information.
Where is the NCT06908824 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong, Poznan, Poland, Taoyuan, Taiwan.
Who is sponsoring the NCT06908824 clinical trial?
NCT06908824 is sponsored by Chinese University of Hong Kong. The principal investigator is Simon KH Szeto, MBChB, FRCOphth at Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong. The trial plans to enroll 180 participants.