Effects of Macular Buckle Versus Vitrectomy on Macular Hole and Macular Detachment in Highly Myopic Eyes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy on Full-thickness Macular Hole and Concurrent Macular Detachment in Eyes With Highly Myopia

Conditions
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Macular Holes, High Myopia, Macular Detachment

Intervention / Treatment
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* Procedure: Buckle
* Procedure: Vitrectomy
* Other: Limbal paracentesis
* Other: Gas injection
* Other: Peeling internal limiting membrane
* Other: Gas tamponade


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter full-thickness macular hole macular retinal detachment evidence of posterior staphyloma on clinical examination Exclusion Criteria: macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant) a history of vitrectomy or scleral buckling intraocular active hemorrhage or inflammation any media opacity which precluded imaging or clinical evaluation of the macula

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buckle<br>Macular buckling, Limbal paracentesis, and intraocular gas injection. | Procedure: Buckle<br>* Surgical procedures of macular buckling<br>* Other names: Implantation of a device of macular buckling;Other: Limbal paracentesis<br>* Drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis<br>Other: Gas injection<br>* Inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous cavity through pars plana.<br>|
| Active Comparator: Vitrectomy<br>Vitrectomy, peeling internal limiting membrane, and gas tamponade. | Procedure: Vitrectomy<br>* Surgical procedures of small gauge vitrectomy<br>Other: Peeling internal limiting membrane<br>* Peeling internal limiting membrane with forceps<br>Other: Gas tamponade<br>* Filling the vitreous cavity with gas (C3F8, 14%)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal re-attachment rate | Successful rate of reattachment of macular retina after surgery | 1 month | 

Secondary Outcome Measures

| Outcome Measure | 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 | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macular buckling, full-thickness macular hole, macular detachment, internal limiting membrane peeling, high myopia