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Macular hole (MH) is a common condition that affects approximately 1.6/1000 elderly Chinese population. The prevalence is expected to be even higher in individuals with high myopia (HM), an established risk factor for MH. Without prompt surgical intervention, it can lead to irreversible vision loss and retinal detachment. Standard MH surgery involves pars plana vitrectomy (PPV) with internal limiting membrane (ILM peeling), followed by endotamponade agents to appose the MH edge.
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Common endotamponade agents include intraocular long-acting gas and silicone oil. The use of endotamponade has its limitations, for example, impairing vision, the need for strict posturing and avoid air travel in the early postoperative period. Ocular complications, such as uveitis, cataract and glaucoma may arise.
To overcome these shortcomings, a novel technique to close MH without endotamponade agents was proposed by a group from Poland. Using viscoelastics to stabilize ILM flap over the MH, negating the need and limitations of endotamponade agents. However, this case series is limited by its small sample size (12 eyes) and lack of patients with pathological myopia (PH).
PH is prevalent in the Asian population and myopic MH tend to have lower surgical success rate due to antero-posterior traction from posterior staphyloma and long axial length associated with PH. There is currently a gap in evidence whether this novel surgical technique could benefit eyes with myopic MH. The investigators plan to conduct a prospective interventional case series to establish the efficacy and safety of myopic MH closure using this novel surgical technique.
Macular hole (MH) is a common condition that affects approximately 1.6/1000 elderly Chinese population. The prevalence is expected to be even higher in individuals with high myopia (HM), an established risk factor for MH. Without prompt surgical intervention, it can lead to irreversible vision loss and retinal detachment. Standard MH surgery involves pars plana vitrectomy (PPV) with internal limiting membrane (ILM peeling), followed by endotamponade agents to appose the MH edge.
Common endotamponade agents include intraocular long-acting gas and silicone oil. The use of endotamponade has its limitations, for example, impairing vision, the need for strict posturing and avoid air travel in the early postoperative period. Ocular complications, such as uveitis, cataract and glaucoma may arise.
To overcome these shortcomings, a novel technique to close MH without endotamponade agents was proposed by a group from Poland. Using viscoelastics to stabilize ILM flap over the MH, negating the need and limitations of endotamponade agents. However, this case series is limited by its small sample size (12 eyes) and lack of patients with pathological myopia (PH).
PH is prevalent in the Asian population and myopic MH tend to have lower surgical success rate due to antero-posterior traction from posterior staphyloma and long axial length associated with PH. There is currently a gap in evidence whether this novel surgical technique could benefit eyes with myopic MH. The investigators plan to conduct a prospective interventional case series to establish the efficacy and safety of myopic MH closure using this novel surgical technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ILM flap with no endotamponade technique | Experimental | Patients with myopic macular hole (MH) will undergo pars plana vitrectomy (PPV) and the internal limiting membrane (ILM) flap with no gas tamponade technique to repair the MH. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ILM flap with no endotamponade technique | Procedure | Standard 3-port pars plana vitrectomy will be performed under either local anesthesia or general anesthesia. After core vitrectomy, posterior vitreous detachment induction will be done using vitrectomy cutter suction with the staining of intravitreal triamcinolone if necessary. This is followed by staining of the ILM with ILM blue dye. A half-moon shaped temporal ILM flap will be created, bridging the MH, using an end-gripping intraocular forceps. The posterior pole would be filled with perfluorocarbon (PFC) liquid and cohesive viscoelastic will be injected under the PFC to stabilize the ILM flap over the MH. Removal of PFC and search for peripheral retinal breaks will be done before removal of vitrectomy trocars and closure of sclerotomies wounds. Surgery will be combined with cataract removal (phacoemulsification) with intraocular lens implantation if patients have visually significant cataract. No specific post-operative posture will be required. |
| Measure | Description | Time Frame |
|---|---|---|
| Macular hole closure rate | Defined as closure of MH on optical coherence tomography (OCT) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative best-corrected visual acuity | BCVA | 12 months |
| MH closure pattern | Grading of MH closure pattern based on OCT | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon KH Szeto, MBChB, FRCOphth | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Eye Hospital | Kowloon | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 40518116 | Background | Szeto SKH, Lam JTW, Yu AHY, Pang CMK, Lin TPH, Hui VWK, Tsang KK, Chan JCK, Chen LJ, Lai TYY, Mohamed S, Tsang CW. Macular Hole Closure by Internal Limiting Membrane Flap without Gas Tamponade versus Conventional Surgery: A Comparative Study. Ophthalmol Retina. 2025 Nov;9(11):1034-1043. doi: 10.1016/j.oret.2025.06.005. Epub 2025 Jun 13. |
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Need organizational approval
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| ID | Term |
|---|---|
| D012167 | Retinal Perforations |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| 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. |