Skip to main content
OpenTrials
Completed

NCT Number: NCT00485199

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of ophthalmology of Beijing Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pneumatic Retinopexy

Procedure

Vitrectomy with Gas

Procedure

Primary outcomes

  1. BCVA improvement,anatomic success

    Time frame: 1,3,6,9, and 12 months after treatment

Secondary outcomes

  1. costs of treatment

    Time frame: right after the treatment

  2. complication

    Time frame: 1,3,6,9, 12 months after treatment

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Acronym: RDMH

Important dates

Study start
2005
Study completion
2006
First posted
Jun 12, 2007
Registry last updated
Jun 12, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.