Status:
RECRUITING
No Endotamponade for Macular Hole Repair: the NEMAR Study
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Poznan University of Medical Sciences
Chang Gung University
Conditions:
Macular Hole
Macular Hole Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
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 vi...
Detailed Description
MH is a common macular condition that requires prompt surgical intervention to prevent irreversible vision loss. Conventional surgical repair of MH involves PPV, ILM peeling and gas tamponade followed...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06908824
Start Date
September 16 2025
End Date
December 31 2027
Last Update
September 30 2025
Active Locations (3)
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1
Hong Kong Eye Hospital
Hong Kong, Hong Kong
2
Poznan University of Medical Sicences, University Hospital in Poznan
Poznan, Poland
3
Chang Gung Memorial Hospital
Taoyuan District, Taiwan