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

This study has been completed.
Sponsor:
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT00485199
First received: June 11, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Retinal Detachment
Procedure: Pneumatic Retinopexy
Procedure: Vitrectomy with Gas

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • BCVA improvement,anatomic success [ Time Frame: 1,3,6,9, and 12 months after treatment ]

Secondary Outcome Measures:
  • costs of treatment [ Time Frame: right after the treatment ]
  • complication [ Time Frame: 1,3,6,9, 12 months after treatment ]

Enrollment: 231
Study Start Date: January 2005
Study Completion Date: December 2006
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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485199

Locations
China, Beijing
Department of ophthalmology of People Hospital, Peking University
Peking, Beijing, China, 100044
Peking Eye Center of the third affiliated Hospital of Peking University
Peking, Beijing, China
Department of ophthalmology of China PLA General Hospital
Peking, Beijing, China
Department of ophthalmology of Beijing Hospital
Peking, Beijing, China
Department of ophthalmology of Beijing Tong Ren Hospital
Peking, Beijing, China
China, Guang Dong
Zhong Shan Ophthalmic Center, Sun Yat-sen University
Guang Zhou, Guang Dong, China
China, Hunan
Department of ophthalmology of The Second affiliated Xiang Ya Hospital, Central South University
Changsha, Hunan, China
China, Jiangsu
Department of ophthalmology of The First affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
China, Liao Ning
Department of ophthalmology of The First affiliated Hospital of China Medical University
Shenyang, Liao Ning, China, 110001
China, Shandong
Shandong Eye Institute
Qingdao, Shandong, China
China, Shang Hai
Department of ophthalmology of The First affiliated People Hospital of Shang Hai Jiao Tong University
Shanghai, Shang Hai, China
China, Shanghai
Department of ophthalmology of EENT Hospital, Fudan University
Shanghai, Shanghai, China
China, Si Chuan
Department of ophthalmology of West China Hospital, Sichuan University
Chengdu, Si Chuan, China
China, Tianjin
Tianjin Eye Hospital
Tianjin, Tianjin, China
Sponsors and Collaborators
Peking University
Investigators
Study Chair: Xiaoxin Li, professor Peking University
Principal Investigator: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00485199     History of Changes
Other Study ID Numbers: RDMH2007-china
Study First Received: June 11, 2007
Last Updated: June 11, 2007
Health Authority: China: Ethics Committee

Keywords provided by Peking University:
Pneumatic Retinopexy
vitrectomy
retinal detachment
macular hole
treatment
multi-center
Retinal Detachment due to Myopic Macular hole

Additional relevant MeSH terms:
Retinal Perforations
Retinal Detachment
Dissociative Disorders
Retinal Diseases
Eye Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014