Clinical trial NCT00485199: Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole
Official title: Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Detachment
Keywords: Pneumatic Retinopexy
vitrectomy
retinal detachment
macular hole
treatment
multi-center
Retinal Detachment due to Myopic Macular hole
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2007-06-12
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 tamponade.To 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 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.

Eligibility 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

Primary outcomes:
measure: BCVA improvement,anatomic success
timeFrame: 1,3,6,9, and 12 months after treatment
Secondary outcomes:
measure: costs of treatment
timeFrame: right after the treatment
measure: complication
timeFrame: 1,3,6,9, 12 months after treatment
Other outcomes:
Locations:
city: Peking
country: China
facility: Department of ophthalmology of People Hospital, Peking University
state: Beijing
city: Peking
country: China
facility: Department of ophthalmology of Beijing Hospital
state: Beijing
city: Peking
country: China
facility: Department of ophthalmology of Beijing Tong Ren Hospital
state: Beijing
city: Peking
country: China
facility: Department of ophthalmology of China PLA General Hospital
state: Beijing
city: Peking
country: China
facility: Peking Eye Center of the third affiliated Hospital of Peking University
state: Beijing
city: Guang Zhou
country: China
facility: Zhong Shan Ophthalmic Center, Sun Yat-sen University
state: Guang Dong
city: Changsha
country: China
facility: Department of ophthalmology of The Second affiliated Xiang Ya Hospital, Central South University
state: Hunan
city: Nanjing
country: China
facility: Department of ophthalmology of The First affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Shenyang
country: China
facility: Department of ophthalmology of The First affiliated Hospital of China Medical University
state: Liao Ning
city: Qingdao
country: China
facility: Shandong Eye Institute
state: Shandong
city: Shanghai
country: China
facility: Department of ophthalmology of The First affiliated People Hospital of Shang Hai Jiao Tong University
state: Shang Hai
city: Shanghai
country: China
facility: Department of ophthalmology of EENT Hospital, Fudan University
state: Shanghai
city: Chengdu
country: China
facility: Department of ophthalmology of West China Hospital, Sichuan University
state: Si Chuan
city: Tianjin
country: China
facility: Tianjin Eye Hospital
state: Tianjin
Study officials:
affiliation: Peking University
name: Xiaoxin Li, professor
role: STUDY_CHAIR
affiliation: Eye Institute of Peking Union Hospital, Peking Union Medical College
name: Jialiang Zhao, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of ophthalmology of Eye Ear Nose Throat Hospital, Fudan University, Shanghai
name: Wenji Wang, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhong Shan Ophthalmic Center, Sun Yat-sen University
name: Shibo Tang, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.