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Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole (RDMH)
This study has been completed.
Study NCT00485199   Information provided by Peking University
First Received: June 11, 2007   No Changes Posted

June 11, 2007
June 11, 2007
January 2005
 
BCVA improvement,anatomic success [ Time Frame: 1,3,6,9, and 12 months after treatment ]
Same as current
No Changes Posted
  • costs of treatment [ Time Frame: right after the treatment ]
  • complication [ Time Frame: 1,3,6,9, 12 months after treatment ]
Same as current
 
Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole
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.

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.

 
Interventional
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Retinal Detachment
  • Procedure: Pneumatic Retinopexy
  • Procedure: Vitrectomy with Gas
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
231
December 2006
 

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00485199
 
RDMH2007-china
Peking University
 
Study Chair: Xiaoxin Li, professor Peking University
Principal Investigator: Jialiang Zhao, professor Eye Institute of Peking Union Hospital, Peking Union Medical College
Principal Investigator: Wenji Wang, professor Department of ophthalmology of Eye Ear Nose Throat Hospital, Fudan University, Shanghai
Principal Investigator: Shibo Tang, professor Zhong Shan Ophthalmic Center, Sun Yat-sen University
Peking University
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP