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

Condition(s) targeted: Retinal Detachment

Intervention: Pneumatic Retinopexy (Procedure); Vitrectomy with Gas (Procedure)

Phase: N/A

Status: Completed

Sponsored by: Peking University

Official(s) and/or principal investigator(s):
Xiaoxin Li, professor, Study Chair, Affiliation: Peking University
Jialiang Zhao, professor, Principal Investigator, Affiliation: Eye Institute of Peking Union Hospital, Peking Union Medical College
Wenji Wang, professor, Principal Investigator, Affiliation: Department of ophthalmology of Eye Ear Nose Throat Hospital, Fudan University, Shanghai
Shibo Tang, professor, Principal Investigator, Affiliation: Zhong Shan Ophthalmic Center, Sun Yat-sen University

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.

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

Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: BCVA improvement,anatomic success

Secondary outcome:

costs of treatment

complication

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 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.

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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

Department of ophthalmology of People Hospital, Peking University, Peking 100044, China

Peking Eye Center of the third affiliated Hospital of Peking University, Peking, China

Department of ophthalmology of China PLA General Hospital, Peking, China

Department of ophthalmology of Beijing Tong Ren Hospital, Peking, China

Department of ophthalmology of Beijing Hospital, Peking, China

Department of ophthalmology of EENT Hospital, Fudan University, Shanghai, China

Tianjin Eye Hospital, Tianjin, China

Zhong Shan Ophthalmic Center, Sun Yat-sen University, Guang Zhou, Guang Dong, China

Department of ophthalmology of The Second affiliated Xiang Ya Hospital, Central South University, Changsha, Hunan, China

Department of ophthalmology of The First affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

Department of ophthalmology of The First affiliated Hospital of China Medical University, Shenyang, Liao Ning 110001, China

Shandong Eye Institute, Qingdao, Shandong, China

Department of ophthalmology of The First affiliated People Hospital of Shang Hai Jiao Tong University, Shanghai, Shang Hai, China

Department of ophthalmology of West China Hospital, Sichuan University, Chengdu, Si Chuan, China

Starting date: January 2005
Ending date: December 2006
Last updated: June 11, 2007