Repairing full-thickness macular holes without using gas (no endotamponade)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.