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Full-thickness macular Hole associated with macular detachment is a one of the maculopathies of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling versus vitrectomy in a cohort of highly myopic eyes with this situation.
A randomized, open label, single center study comparing the efficacy of macular muckle + gas injection versus internal limiting membrane peeling + gas tamponade on full-thickness macular hole associated with macular detachment in eyes with high myopia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buckle | Experimental | Macular buckling, Limbal paracentesis, and intraocular gas injection. |
|
| Vitrectomy | Active Comparator | Vitrectomy, peeling internal limiting membrane, and gas tamponade. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buckle | Procedure | Surgical procedures of macular buckling |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Retinal re-attachment rate | Successful rate of reattachment of macular retina after surgery | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Macular hole status | Closure rate of macular hole after surgery on optical coherence tomography | 3 month |
| Post-operative best corrected visual acuity | Best corrected visual acuity of the eyes after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lin Lu, MD,PhD | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33397654 | Derived | Zhao X, Li Y, Ma W, Lian P, Yu X, Chen S, Huang X, Liu B, Lu L. Macular buckling versus vitrectomy on macular hole associated macular detachment in eyes with high myopia: a randomised trial. Br J Ophthalmol. 2022 Apr;106(4):582-586. doi: 10.1136/bjophthalmol-2020-317800. Epub 2021 Jan 4. | |
| 32408387 | Derived |
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| Vitrectomy | Procedure | Surgical procedures of small gauge vitrectomy |
|
| Limbal paracentesis | Other | Drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis |
|
| Gas injection | Other | Inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous cavity through pars plana. |
|
| Peeling internal limiting membrane | Other | Peeling internal limiting membrane with forceps |
|
| Gas tamponade | Other | Filling the vitreous cavity with gas (C3F8, 14%) |
|
| 3 month |
| Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4. |
| ID | Term |
|---|---|
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014821 | Vitrectomy |
| D005740 | Gases |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D007287 | Inorganic Chemicals |
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