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

Retinal Detachment Clinical Trial

— RDMH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485199
• Other study ID #: RDMH2007-china
• Status: Completed
• Phase: N/A
• First received: June 11, 2007
• Last updated: June 11, 2007
• Start date: January 2005
• Est. completion date: December 2006

Study information

• Verified date: June 2007
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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 tamponade.To determine the efficiency of pneumatic retinopexy with C3F8 in the treatment of retinal detachment due to myopic macular hole.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment

Intervention

Procedure:
• Pneumatic Retinopexy

• Vitrectomy with Gas

Locations

Country	Name	City	State
China	Department of ophthalmology of The Second affiliated Xiang Ya Hospital, Central South University	Changsha	Hunan
China	Department of ophthalmology of West China Hospital, Sichuan University	Chengdu	Si Chuan
China	Zhong Shan Ophthalmic Center, Sun Yat-sen University	Guang Zhou	Guang Dong
China	Department of ophthalmology of The First affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Department of ophthalmology of Beijing Hospital	Peking	Beijing
China	Department of ophthalmology of Beijing Tong Ren Hospital	Peking	Beijing
China	Department of ophthalmology of China PLA General Hospital	Peking	Beijing
China	Department of ophthalmology of People Hospital, Peking University	Peking	Beijing
China	Peking Eye Center of the third affiliated Hospital of Peking University	Peking	Beijing
China	Shandong Eye Institute	Qingdao	Shandong
China	Department of ophthalmology of EENT Hospital, Fudan University	Shanghai	Shanghai
China	Department of ophthalmology of The First affiliated People Hospital of Shang Hai Jiao Tong University	Shanghai	Shang Hai
China	Department of ophthalmology of The First affiliated Hospital of China Medical University	Shenyang	Liao Ning
China	Tianjin Eye Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCVA improvement,anatomic success		1,3,6,9, and 12 months after treatment
Secondary	costs of treatment		right after the treatment
Secondary	complication		1,3,6,9, 12 months after treatment