Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole

Study Overview
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Brief Summary
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To undertake a prospective randomized clinical study for treating retinal detachment due to myopic macular holes, utilizing pneumatic retinopexy versus pars plana vitrectomy with gas tamponade.To determine the efficiency of pneumatic retinopexy with C3F8 in the treatment of retinal detachment due to myopic macular hole.

Detailed Description
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Retinal detachment caused by macular hole predominantly happened in high myopic eyes. This is a common type of retinal detachment in Asia and often seen in the old people aged around 50   60, mainly in female. Treatment of retinal detachment due to macular holes has changed over the years, and several methods have been described. Some surgeons have used transscleral diathermy or cryotherapy or laser photocoagulation and drainage subretinal fluid without sclera buckling, other surgeons have used radial silicone explants beneath the macular combined with cryo, diathermy or laser. This method entails the difficulty of placing sclera sutures far posterior, especially hazardous if there is a posterior staphyloma with very thin sclera. Besides the technically difficult, the extensive macular scarring caused by different coagulations limited the functional result to peripheral vision only. Because of this, it is not generally used in the initial treatment. In 1982, Gonvers and Machemer4 proposed a new treatment technique that combined pars plana vitrectomy (PPV), partial air-fluid exchange, and face down positioning for 24 hours. Since then vitrectomy with gas tamponade become the most common procedure for retinal detachment with macular hole. In 1984, Miyake performed a simple gas injection into the vitreous followed by a face-down position. The effective of this simplified method was then reported by many observers.But these studies may have insufficiency because of small sample, nonrandomized, no defined eligibility criteria for patients selection. Intraocular gas tamponade with or without pars plana vitrectomy (PPV) has commonly been performed nowadays. We conducted a multicenter randomized controlled clinical trial to compare their anatomic results and visual outcomes of both surgical techniques, to estimate the efficiency of both surgical methods in the treatment of retinal detachment with myopic macular hole.

Official Title
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Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole

Conditions
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Retinal Detachment

Intervention / Treatment
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* Procedure: Pneumatic Retinopexy
* Procedure: Vitrectomy with Gas


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: retinal detachment due to myopic macular hole. The ability to give informed consent and to return for follow-up visit for 12 months Exclusion Criteria: retinal detachment with macular hole and peripheral hole/tear retinal detachment with severe proliferative vitreoretinopathy retinal detachment with choroidal detachment or rupture traction retinal detachment due to retinal vascular disease had vitrectomy in the past macular hole without retinal detachment foveal schiesis without retinal detachment secondary macular hole with retinal detachment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pneumatic Retinopexy|nan|
|Procedure: Vitrectomy with Gas|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA improvement,anatomic success |  | 1,3,6,9, and 12 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| costs of treatment |  | right after the treatment | 
| complication |  | 1,3,6,9, 12 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumatic Retinopexy, vitrectomy, retinal detachment, macular hole, treatment, multi-center, Retinal Detachment due to Myopic Macular hole