NCT Number: NCT00485199
Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole
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.
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Notify MeKey information
Age range
18 year–90 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Department of ophthalmology of Beijing Hospital, Beijing, Beijing Municipality, China
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Vitrectomy with Gas
ProcedurePrimary outcomes
-
BCVA improvement,anatomic success
Time frame: 1,3,6,9, and 12 months after treatment
Secondary outcomes
-
costs of treatment
Time frame: right after the treatment
-
complication
Time frame: 1,3,6,9, 12 months after treatment
Sponsors and collaborators
Lead sponsor
Peking University
Other
Registry information
Acronym: RDMH
Important dates
- Study start
- 2005
- Study completion
- 2006
- First posted
- Jun 12, 2007
- Registry last updated
- Jun 12, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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