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

October 8, 2018 updated by: Lin Lu, Sun Yat-sen University

A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy on Full-thickness Macular Hole and Concurrent Macular Detachment in Eyes With Highly Myopia

Full-thickness macular Hole associated with macular detachment is a one of the maculopathies of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling versus vitrectomy in a cohort of highly myopic eyes with this situation.

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 full-thickness macular hole associated with macular detachment in eyes with high myopia.

Study Type

Interventional

Enrollment (Actual)

50

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, Sun Yat-sen University

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
  • full-thickness macular hole
  • macular retinal detachment
  • evidence of posterior staphyloma on clinical examination

Exclusion Criteria:

  • macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)
  • a history of vitrectomy or scleral buckling
  • 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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Buckle
Macular buckling, Limbal paracentesis, and intraocular gas injection.
Procedure: Buckle
Surgical procedures of macular buckling
Other Names:
  • Implantation of a device of macular buckling
Other: Limbal paracentesis
Drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis
Other: Gas injection
Inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous cavity through pars plana.
ACTIVE_COMPARATOR: Vitrectomy
Vitrectomy, peeling internal limiting membrane, and gas tamponade.
Procedure: Vitrectomy
Surgical procedures of small gauge vitrectomy
Other: Peeling internal limiting membrane
Peeling internal limiting membrane with forceps
Other: Gas tamponade
Filling the vitreous cavity with gas (C3F8, 14%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal re-attachment rate
Time Frame: 1 month
Successful rate of reattachment of macular retina after surgery
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Macular hole status
Time Frame: 3 month
Closure rate of macular hole after surgery on optical coherence tomography
3 month
Post-operative best corrected visual acuity
Time Frame: 3 month
Best corrected visual acuity of the eyes after surgery
3 month

Collaborators and Investigators

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

Sponsor

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 (ACTUAL)

January 30, 2018

Primary Completion (ACTUAL)

July 20, 2018

Study Completion (ACTUAL)

August 20, 2018

Study Registration Dates

First Submitted

January 23, 2018

First Submitted That Met QC Criteria

February 8, 2018

First Posted (ACTUAL)

February 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 8, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013meky013-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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