Quantifying metamorphopsia with M-CHARTS in patients with idiopathic macular hole.
Iori Wada, Shigeo Yoshida, Yoshiyuki Kobayashi...
https://pubmed.ncbi.nlm.nih.gov/29033537Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06908824
No Endotamponade for Macular Hole Repair: International Randomized Trial Comparing ILM Flap Without Gas Versus Conventional Surgery
Led by Chinese University of Hong Kong · Updated on 2025-09-30
180
Participants Needed
3
Research Sites
N/A
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
Macular hole (MH) is a common condition that can seriously affect vision, with a prevalence of 3.3 per 1000 people. If untreated, most patients experience worsening central vision, often reaching severe visual loss. Prompt surgical repair is important to prevent permanent vision damage. This study compares two surgical methods to treat MH: the standard conventional surgery using gas tamponade and a newer technique using an internal limiting membrane (ILM) flap without gas tamponade. The two surgical techniques studied are: 1) Conventional surgery involving pars plana vitrectomy (PPV) with ILM peeling and gas or silicone oil tamponade, followed by face-down positioning for at least 5 days; and 2) ILM flap surgery without gas tamponade, where patients avoid excessive movement and maintain a face-forward or supine position for 24 hours after surgery, then have no posturing restrictions. Both surgeries may include cataract surgery if needed. Participants are randomly assigned to one of these groups. Participants will undergo baseline screening and then post-operative follow-up visits to monitor visual acuity, retinal imaging, and routine eye exams. Researchers will measure macular hole closure at 3 months as the primary outcome and assess visual function and retinal changes up to 12 months. The study aims to evaluate the safety and efficacy of the two surgical approaches, with ongoing monitoring throughout the study duration.
CONDITIONS
Brief Title
No Endotamponade for Macular Hole Repair: the NEMAR Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Full thickness macular hole in one eye confirmed by optical coherence tomography
- Able to comply with post-operative positioning instructions
- Visual acuity between 0.05 and 0.8
You will not qualify if you...
- Fellow eye already enrolled in the study
- Previous macular surgery in either eye
- Presence of other maculopathy besides macular hole, epiretinal membrane, or myopic maculopathy
- Axial length 28 mm or more or significant myopic chorio-retinal atrophy involving the fovea
- Minimum linear diameter of the macular hole 800 micrometers or more
- Contraindications to intraocular gas, such as advanced or uncontrolled glaucoma
- Significant macular puckering (Govetto stage 2 or higher)
- Unable to give informed consent
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery and first 5 days post-operative
Participants undergo macular hole repair surgery using either conventional surgery with gas tamponade or ILM flap with no gas tamponade technique. Post-operative posturing instructions differ by surgical technique.
1 surgery visit plus post-operative instructions
Post-operative Follow-up
Duration - Up to 12 months
Participants attend follow-up visits for routine clinical examinations, visual acuity checks, and retinal imaging to monitor recovery and surgical outcomes.
Multiple follow-up visits over 12 months
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
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Research Team
S
Simon KH Dr Szeto, MBChB, MSc, FRCOphth
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Vision Preference Value Scale and Patient Preferences in Choosing Therapy for Symptomatic Vitreomacular Interface Abnormality.
Marguerite O Linz, Neil M Bressler, Voraporn Chaikitmongkol...
https://pubmed.ncbi.nlm.nih.gov/29800983Development of a Chinese version of the National Eye Institute Visual Function Questionnaire (CHI-VFQ-25) as a tool to study patients with eye diseases in Hong Kong.
C W S Chan, D Wong, C L K Lam...
https://pubmed.ncbi.nlm.nih.gov/19515645Macular Hole Closure Without Endotamponade Application.
Marcin Stopa, Maksym Ciesielski, Piotr Rakowicz
https://pubmed.ncbi.nlm.nih.gov/32453068COMPLEX MACULAR HOLE CLOSURE BY TEMPORAL INTERNAL LIMITING MEMBRANE FLAP WITHOUT ENDOTAMPONADE.
Simon K H Szeto, Amy H Y Yu, Chi Wai Tsang...
https://pubmed.ncbi.nlm.nih.gov/39436300