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

October 12, 2017 updated by: Lin Lu, Sun Yat-sen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

80

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Ophthalmic Center

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Buckle
Macular buckling and intraocular gas (C3F8) injection.
Procedure: Macular buckling
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.
Active Comparator: Vitrectomy
Vitrectomy, internal limiting membrane peeling, and gas tamponade (C3F8).
Procedure: Vitrectomy
Surgical procedures of small gauge vitrectomy, internal limiting membrane peeling, and gas (C3F8, 14%) tamponage, under local or systemic anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retinal re-attachment rate
Time Frame: 3 month
3 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Post-operative best corrected visual acuity
Time Frame: 12 month
12 month
Post-operative macular structure on optical coherance tomography
Time Frame: 12 month
12 month

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

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

April 1, 2015

Primary Completion (Actual)

January 30, 2017

Study Completion (Actual)

October 12, 2017

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 16, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

October 16, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013meky013(2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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