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

June 11, 2007 updated by: Peking 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Peking, Beijing, China, 100044
        • Department of ophthalmology of People Hospital, Peking University
      • Peking, Beijing, China
        • Department of ophthalmology of Beijing Hospital
      • Peking, Beijing, China
        • Department of ophthalmology of Beijing Tong Ren Hospital
      • Peking, Beijing, China
        • Department of ophthalmology of China PLA General Hospital
      • Peking, Beijing, China
        • Peking Eye Center of the third affiliated Hospital of Peking University
    • Guang Dong
      • Guang Zhou, Guang Dong, China
        • Zhong Shan Ophthalmic Center, Sun Yat-sen University
    • Hunan
      • Changsha, Hunan, China
        • Department of ophthalmology of The Second affiliated Xiang Ya Hospital, Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Department of ophthalmology of The First affiliated Hospital of Nanjing Medical University
    • Liao Ning
      • Shenyang, Liao Ning, China, 110001
        • Department of ophthalmology of The First affiliated Hospital of China Medical University
    • Shandong
      • Qingdao, Shandong, China
        • Shandong Eye Institute
    • Shang Hai
      • Shanghai, Shang Hai, China
        • Department of ophthalmology of The First affiliated People Hospital of Shang Hai Jiao Tong University
    • Shanghai
      • Shanghai, Shanghai, China
        • Department of ophthalmology of EENT Hospital, Fudan University
    • Si Chuan
      • Chengdu, Si Chuan, China
        • Department of ophthalmology of West China Hospital, Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China
        • TianJin eye hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BCVA improvement,anatomic success
Time Frame: 1,3,6,9, and 12 months after treatment
1,3,6,9, and 12 months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
costs of treatment
Time Frame: right after the treatment
right after the treatment
complication
Time Frame: 1,3,6,9, 12 months after treatment
1,3,6,9, 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

June 11, 2007

First Submitted That Met QC Criteria

June 11, 2007

First Posted (Estimate)

June 12, 2007

Study Record Updates

Last Update Posted (Estimate)

June 12, 2007

Last Update Submitted That Met QC Criteria

June 11, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDMH2007-china

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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