Actively Recruiting
No Endotamponade for Macular Hole Repair: the NEMAR Study
Led by Chinese University of Hong Kong · Updated on 2025-09-30
180
Participants Needed
3
Research Sites
119 weeks
Total Duration
On this page
Sponsors
C
Chinese University of Hong Kong
Lead Sponsor
P
Poznan University of Medical Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
No Endotamponade for Macular Hole Repair: the NEMAR Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �3A 18 years
- Presence of full thickness macular hole in one eye confirmed by optical coherence tomography
- Able to comply with post-operative posture instructions
- Visual acuity between 0.05 and 0.8
You will not qualify if you...
- Fellow eye enrolled in the study
- Previous macular surgery in the affected eye
- Presence of maculopathy other than macular hole, epiretinal membrane, or myopic maculopathy
- Axial length �3E= 28 mm or significant myopic chorio-retinal atrophy involving the fovea
- Minimum linear diameter of macular hole �3E= 800 Bcm
- Contraindications to intraocular gas such as advanced or uncontrolled glaucoma
- Significant macular puckering (Govetto staging �3E= stage 2)
- Unable to give informed consent
- Pregnant patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Hong Kong Eye Hospital
Hong Kong, Hong Kong
Actively Recruiting
2
Poznan University of Medical Sicences, University Hospital in Poznan
Poznan, Poland
Not Yet Recruiting
3
Chang Gung Memorial Hospital
Taoyuan, Taiwan
Not Yet Recruiting
Research Team
S
Simon KH Dr Szeto, MBChB, MSc, FRCOphth
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here