Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00485199
Status:
COMPLETED
Last Update Posted:
2007-06-12
First Post:
2007-06-11
Brief Title:
Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole
Sponsor:
Peking University
Organization:
Peking University
Study Overview
Official Title:
Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RDMH
Brief Summary:
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 tamponadeTo determine the efficiency of pneumatic retinopexy with C3F8 in the treatment of retinal detachment due to myopic macular hole
Detailed Description:
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 observersBut 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
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 observersBut 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None