Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole (RDMH)
Primary Purpose
Retinal Detachment
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pneumatic Retinopexy
Vitrectomy with Gas
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Detachment focused on measuring Pneumatic Retinopexy, vitrectomy, retinal detachment, macular hole, treatment, multi-center, Retinal Detachment due to 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
Sites / Locations
- Department of ophthalmology of People Hospital, Peking University
- Department of ophthalmology of Beijing Hospital
- Department of ophthalmology of Beijing Tong Ren Hospital
- Department of ophthalmology of China PLA General Hospital
- Peking Eye Center of the third affiliated Hospital of Peking University
- Zhong Shan Ophthalmic Center, Sun Yat-sen University
- Department of ophthalmology of The Second affiliated Xiang Ya Hospital, Central South University
- Department of ophthalmology of The First affiliated Hospital of Nanjing Medical University
- Department of ophthalmology of The First affiliated Hospital of China Medical University
- Shandong Eye Institute
- Department of ophthalmology of The First affiliated People Hospital of Shang Hai Jiao Tong University
- Department of ophthalmology of EENT Hospital, Fudan University
- Department of ophthalmology of West China Hospital, Sichuan University
- Tianjin Eye Hospital
Outcomes
Primary Outcome Measures
BCVA improvement,anatomic success
Secondary Outcome Measures
costs of treatment
complication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00485199
Brief Title
Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole
Acronym
RDMH
Official Title
Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Peking University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
Keywords
Pneumatic Retinopexy, vitrectomy, retinal detachment, macular hole, treatment, multi-center, Retinal Detachment due to Myopic Macular hole
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
231 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Pneumatic Retinopexy
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy with Gas
Primary Outcome Measure Information:
Title
BCVA improvement,anatomic success
Time Frame
1,3,6,9, and 12 months after treatment
Secondary Outcome Measure Information:
Title
costs of treatment
Time Frame
right after the treatment
Title
complication
Time Frame
1,3,6,9, 12 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoxin Li, professor
Organizational Affiliation
Peking University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jialiang Zhao, professor
Organizational Affiliation
Eye Institute of Peking Union Hospital, Peking Union Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wenji Wang, professor
Organizational Affiliation
Department of ophthalmology of Eye Ear Nose Throat Hospital, Fudan University, Shanghai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shibo Tang, professor
Organizational Affiliation
Zhong Shan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of ophthalmology of People Hospital, Peking University
City
Peking
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Department of ophthalmology of Beijing Hospital
City
Peking
State/Province
Beijing
Country
China
Facility Name
Department of ophthalmology of Beijing Tong Ren Hospital
City
Peking
State/Province
Beijing
Country
China
Facility Name
Department of ophthalmology of China PLA General Hospital
City
Peking
State/Province
Beijing
Country
China
Facility Name
Peking Eye Center of the third affiliated Hospital of Peking University
City
Peking
State/Province
Beijing
Country
China
Facility Name
Zhong Shan Ophthalmic Center, Sun Yat-sen University
City
Guang Zhou
State/Province
Guang Dong
Country
China
Facility Name
Department of ophthalmology of The Second affiliated Xiang Ya Hospital, Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Department of ophthalmology of The First affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Department of ophthalmology of The First affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liao Ning
ZIP/Postal Code
110001
Country
China
Facility Name
Shandong Eye Institute
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
Department of ophthalmology of The First affiliated People Hospital of Shang Hai Jiao Tong University
City
Shanghai
State/Province
Shang Hai
Country
China
Facility Name
Department of ophthalmology of EENT Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Department of ophthalmology of West China Hospital, Sichuan University
City
Chengdu
State/Province
Si Chuan
Country
China
Facility Name
Tianjin Eye Hospital
City
Tianjin
State/Province
Tianjin
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
32408387
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.
Results Reference
derived
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Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole
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