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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-12-31

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.

Conditions

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Retinal Detachment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Pneumatic Retinopexy

Intervention Type PROCEDURE

Vitrectomy with Gas

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Xiaoxin Li, professor

Role: STUDY_CHAIR

Peking University

Jialiang Zhao, professor

Role: PRINCIPAL_INVESTIGATOR

Eye Institute of Peking Union Hospital, Peking Union Medical College

Wenji Wang, professor

Role: PRINCIPAL_INVESTIGATOR

Department of ophthalmology of Eye Ear Nose Throat Hospital, Fudan University, Shanghai

Shibo Tang, professor

Role: PRINCIPAL_INVESTIGATOR

Zhong Shan Ophthalmic Center, Sun Yat-sen University

Locations

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