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| Name | Class |
|---|---|
| Poznan University of Medical Sciences | OTHER |
| Chang Gung University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional surgery | Active Comparator | 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. |
|
| Internal limiting membrane (ILM) flap with no gas tamponade | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) in the study eye | Best corrected visual acuity will be checked using the Snellen visual acuity chart | 12 months |
| Pattern of macular hole closure | The pattern of macular hole closure will be assessed on optical coherence tomography |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Retinal sensitivity |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simon KH Dr Szeto, MBChB, MSc, FRCOphth | Contact | 852 39435886 | simonkhszeto@cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Simon KH Szeto, MBChB, FRCOphth | Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Eye Hospital | Recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29033537 | Background | Wada I, Yoshida S, Kobayashi Y, Zhou Y, Ishikawa K, Nakao S, Hisatomi T, Ikeda Y, Ishibashi T, Sonoda KH. Quantifying metamorphopsia with M-CHARTS in patients with idiopathic macular hole. Clin Ophthalmol. 2017 Sep 20;11:1719-1726. doi: 10.2147/OPTH.S144981. eCollection 2017. | |
| 29800983 | Background | Linz MO, Bressler NM, Chaikitmongkol V, Sivaprasad S, Patikulsila D, Choovuthayakorn J, Watanachai N, Kunavisarut P, Menon D, Tadarati M, Delalibera Pacheco K, Sanyal A, Scott AW. Vision Preference Value Scale and Patient Preferences in Choosing Therapy for Symptomatic Vitreomacular Interface Abnormality. JAMA Ophthalmol. 2018 Jun 1;136(6):658-664. doi: 10.1001/jamaophthalmol.2018.1272. |
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| ID | Term |
|---|---|
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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|
| ILM flap with no gas tamponade | Procedure | 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. |
|
| 12 months |
| Rate of foveal gliosis | Based on optical coherence tomography. | 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. | 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. | 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. | 12 months |
Microperimetry will be performed to assess the retinal sensitivity. This is an exploratory outcome and will be performed in selected patients only.
| 12 months |
| Poznan University of Medical Sicences, University Hospital in Poznan | Not yet recruiting | Poznan | Poland |
|
| Chang Gung Memorial Hospital | Not yet recruiting | Taoyuan | Taiwan |
|
| 19515645 | Background | Chan CW, Wong D, Lam CL, McGhee S, Lai WW. Development 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. Br J Ophthalmol. 2009 Nov;93(11):1431-6. doi: 10.1136/bjo.2009.158428. Epub 2009 Jun 9. |
| 32453068 | Background | Stopa M, Ciesielski M, Rakowicz P. Macular Hole Closure Without Endotamponade Application. Retina. 2023 Apr 1;43(4):688-691. doi: 10.1097/IAE.0000000000002850. Epub 2020 May 25. |
| 39436300 | Background | Szeto SKH, Yu AHY, Tsang CW, Mohamed S, Chen LJ, Lai TYY. COMPLEX MACULAR HOLE CLOSURE BY TEMPORAL INTERNAL LIMITING MEMBRANE FLAP WITHOUT ENDOTAMPONADE. Retina. 2024 Nov 1;44(11):1915-1922. doi: 10.1097/IAE.0000000000004201. |