An interventional study of Conventional surgery and ILM flap with no gas tamponade in Macular Hole and Macular Hole Surgery, sponsored by Chinese University of Hong Kong. Recruiting at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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:
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 by post-operative face down posturing. The use of gas tamponade, however, is associated with impairment of vision in the early post-operative period and restriction of air travel. Moreover, fluorinated ophthalmic gases are potent green house gases that contribute to global warming.
Recently, a novel surgical technique to repair MH without endotamponade has been proposed, termed the ILM flap with no gas tamponade technique.
There is currently no published randomised controlled trial comparing the efficacy and safety of MH repair using conventional surgical technique and the ILM flap with no gas tamponade technique.
Patients with confirmed full thickness MH on optical coherence tomography will be screened and invited to join the study. Written informed consent will be obtained. Baseline screening will be performed.
Recruited study participants will be randomly allocated to one of the two study groups:
Participants will be instructed to attend post-operative follow up visits to undergo routine clinical examination, visual acuity checking and retinal imaging performed.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's planned enrollment of 180 is above the median of 50 across 94 interventional studies indexed under Retinal Perforations.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients would undergo conventional surgery to repair macular hole and be instructed to adopt a face-down posturing in the first 5 days following operation.
Procedure: Conventional surgery
Patients would undergo macular hole repair by the ILM flap with no gas tamponade technique. Patients will be instructed to avoid excessive movement and adopt a sit up/supine posture for the first 24 hours, beyond which there will be no posturing restriction.
Procedure: ILM flap with no gas tamponade
Pars plana vitrectomy (PPV) with temporal internal limiting membrane (ILM) flap would be performed. Perfluorocarbon liquid (PFCL) or viscoelastic may be used as an adjunct. Air/Fluid exchange would be performed at the end of surgery, further exchange of air with 8-14% octafluoropropane (C3F8) would be performed based on operating surgeon's discretion. In cases a temporal ILM flap could not be created, an ILM flap would be created from other quadrants, for example, a nasal ILM would be created instead. Patients with visually significant cataract may undergo concomitant phacoemulsification and intraocular lens implantation or deferred to post-operative month 6-12. Patients would be instructed to adopt a face-down posturing in the first 5 days following operation.
Pars plana vitrectomy with temporal internal limiting membrane (ILM) flap would be performed. The ILM flap would be stabilised over the macular hole using perfluorocarbon liquid (PFCL) followed by sub-PFCL dispersive viscoelastic injection. The PFCL would be removed towards the end of surgery. In cases a temporal ILM flap could not be created, an ILM flap would be created from other quadrants, for example, a nasal ILM would be created instead. Concomitant phacoemulsification and intraocular lens implantation would be performed in patients with visually significant cataract or deferred to post-operative month 6-12. Patients will be instructed to avoid excessive movement and adopt a face forward/ supine position for first 24 hours. Afterwards, there would be no restriction on post-operative posturing.
Macular hole closure rate
The primary outcome is the macular hole closure rate without additional vitrectomy/macular surgery at post-operative month 3. Closure of macular hole is defined as the presence of continuous retinal tissue over the retinal pigment epithelium (RPE) without bare RPE exposed to vitreous cavity on optical coherence tomography (OCT).
Time frame: 3 months
Best Corrected Visual Acuity (BCVA) in the study eye
Best corrected visual acuity will be checked using the Snellen visual acuity chart
Time frame: 12 months
Pattern of macular hole closure
The pattern of macular hole closure will be assessed on optical coherence tomography
Time frame: 12 months
Rate of foveal gliosis
Based on optical coherence tomography.
Time frame: 12 months
Patients reported visual function
The patient reported visual function will be assessed using the National Eye Institute 25-item visual function questionnaire (NEI VFQ-25). The score ranges from 0-100, with higher score indicating better visual function.
Time frame: 12 months
Vision Preference Value Scale
Using a previously validated questionnaire to determine vision preference value and treatment preferences. Preference values were graded on a scale from 0 to 1, with 0 indicating death and 1 indicating perfect health with perfect vision.
Time frame: 12 months
Metamorphosia score
Using M-CHARTS (Inami \& Co., Ltd., Tokyo, Japan) Ranges from 0-10. 0 indicates no metamorphopsia and 10 indicates severe metamorphopsia.
Time frame: 12 months
Number of participants with surgery related adverse events
Include all post-operative complications, such as endophthalmitis, retinal detachment, re-opening of macular hole, intraocular pressure spike and hypotony.
Time frame: 12 months
Retinal sensitivity
Microperimetry will be performed to assess the retinal sensitivity. This is an exploratory outcome and will be performed in selected patients only.
Time frame: 12 months
Plan to share: No
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