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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumatic Retinopexy | Procedure | |||
| Vitrectomy with Gas | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA improvement,anatomic success | 1,3,6,9, and 12 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| costs of treatment | right after the treatment | |
| complication | 1,3,6,9, 12 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoxin Li, professor | Peking University | Study Chair |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of ophthalmology of People Hospital, Peking University | Beijing | Beijing Municipality | 100044 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32408387 | Derived | 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. |
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| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014821 | Vitrectomy |
| D005740 | Gases |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D007287 | Inorganic Chemicals |
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| Department of ophthalmology of Beijing Hospital |
| Beijing |
| Beijing Municipality |
| China |
| Department of ophthalmology of Beijing Tong Ren Hospital | Beijing | Beijing Municipality | China |
| Department of ophthalmology of China PLA General Hospital | Beijing | Beijing Municipality | China |
| Peking Eye Center of the third affiliated Hospital of Peking University | Beijing | Beijing Municipality | China |
| Zhong Shan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong | 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 | Liaoning | 110001 | China |
| Shandong Eye Institute | Qingdao | Shandong | China |
| Department of ophthalmology of EENT Hospital, Fudan University | Shanghai | Shanghai Municipality | China |
| Department of ophthalmology of The First affiliated People Hospital of Shang Hai Jiao Tong University | Shanghai | Shanghai Municipality | China |
| Department of ophthalmology of West China Hospital, Sichuan University | Chengdu | Sichuan | China |
| Tianjin Eye Hospital | Tianjin | Tianjin Municipality | China |