Repairing full-thickness macular holes without using gas (no endotamponade)
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
NA · Chinese University of Hong Kong · NCT06908824
This trial sees if an internal limiting membrane (ILM) flap technique that omits gas can close full-thickness macular holes in adults as safely and effectively as the usual vitrectomy with gas tamponade.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 3 sites (Hong Kong and 2 other locations) |
| Trial ID | NCT06908824 on ClinicalTrials.gov |
What this trial studies
This is a prospective, international, randomized controlled trial comparing two surgical approaches for full-thickness macular hole repair. One arm receives conventional pars plana vitrectomy with ILM peeling and intraocular gas tamponade plus face-down posturing, while the other arm receives an ILM flap technique with no gas and no posturing restriction. Adults with OCT-confirmed full-thickness macular holes who meet size and ocular health criteria are randomized and followed for anatomical closure and safety outcomes. The trial is conducted at multiple centers in Hong Kong, Poland, and Taiwan to capture diverse patient populations and surgical practice patterns.
Who should consider this trial
Good fit: Adults (≥18 years) with an OCT-confirmed full-thickness macular hole, visual acuity between approximately 0.05 and 0.8, no prior macular surgery, and without other significant macular disease or extreme myopia are ideal candidates.
Not a fit: Patients with very large holes (minimum linear diameter ≥800 µm), prior macular surgery, other central maculopathies, uncontrolled glaucoma, marked myopic chorioretinal atrophy, or pregnancy are unlikely to benefit or are excluded from this approach.
Why it matters
Potential benefit: If successful, the no-gas technique could achieve comparable hole closure while sparing patients early postoperative vision impairment, face-down positioning, air-travel restrictions, and exposure to ophthalmic greenhouse gases.
How similar studies have performed: Retrospective case series and early reports have shown encouraging results for ILM flap techniques without gas, but randomized controlled data directly comparing no-gas versus conventional gas tamponade are not yet published.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong and 2 other locations
- Hong Kong Eye Hospital — Hong Kong, Hong Kong (RECRUITING)
- Poznan University of Medical Sicences, University Hospital in Poznan — Poznan, Poland (NOT_YET_RECRUITING)
- Chang Gung Memorial Hospital — Taoyuan, Taiwan (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Simon KH Szeto, MBChB, FRCOphth — Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong
- Study coordinator: Simon KH Dr Szeto, MBChB, MSc, FRCOphth
- Email: simonkhszeto@cuhk.edu.hk
- Phone: 852 39435886
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Macular Hole, Macular Hole Surgery, Vitrectomy, Macular surgery, Internal limiting membrane peeling, Gas tamponade