Skip to main content
OpenTrials
Completed

NCT Number: NCT03023800

Effects of Macular Buckle Versus Vitrectomy on Macular Schisis and Macular Detachment in Highly Myopic Eyes

Macular schisis associated with macular detachment is a one of the complications of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular retinal detachment associated with macular schisis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Retinoschisis Eye Diseases High Myopia Macular Detachment Retinal Degeneration Retinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

About this study

A randomized, open label, single center study comparing the efficacy of macular muckle + gas injection versus internal limiting membrane peeling + gas tamponade on macular schisis associated with macular detachment in eyes with high myopia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter
  • macular schisis
  • macular retinal detachment
  • evidence of posterior staphyloma on clinical examination

Exclusion criteria

  • severe macular scar
  • macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)
  • prominent vitreomacular traction
  • a history of vitrectomy or macular buckle
  • intraocular active hemorrhage or inflammation
  • any media opacity which precluded imaging or clinical evaluation of the macula

Treatment and study plan

Macular buckling

Procedure

Surgical procedures of macular buckling, drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis, and inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous body through pars plana, under systemic anesthesia.

Vitrectomy

Procedure

Surgical procedures of small gauge vitrectomy, internal limiting membrane peeling, and gas (C3F8, 14%) tamponage, under local or systemic anesthesia

Primary outcomes

  1. Retinal re-attachment rate

    Time frame: 3 month

Secondary outcomes

  1. Post-operative best corrected visual acuity

    Time frame: 12 month

  2. Post-operative macular structure on optical coherance tomography

    Time frame: 12 month

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy + Internal Limiting Membrane Peeling + Gas Tamponade on Macular Schisis and Concurrent Macular Detachment in Eyes With Highly Myopia

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 18, 2017
Registry last updated
Oct 16, 2017

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.

Related clinical trials

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