Macular Hole Surgery With and Without Internal Limiting Membrane Peeling：A Systematic Review and Meta-analysis

February 12, 2014 updated by: Yifan Feng
Since Kelly and Wendel first reported successful closure of idiopathic macular holes (MH) by vitrectomy in 1991, many surgical modifications have been made to improve the anatomical and visual outcomes of this surgery. Recently, internal limiting membrane (ILM) peeling has become used widely as an adjunctive procedure during MH surgery because the removal of ILM is thought to reduce the tangential traction on the macula, a major factor in the pathogenesis of idiopathic macular holes. However, the role of ILM peeling in macular hole surgery is not yet well defined. To the best of our knowledge, there is no meta-analysis on comparison of the efficacy of ILM peeling and suture for MH surgery. This study reviewed the published literature comparing surgical results with and without ILM peeling and and performed a meta-analysis to determine whether there is any benefit or detriment anatomically and/or visually.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

400

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
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • Wenzhou Medical College
        • Contact:
        • Principal Investigator:
          • Yifan Feng, MD

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients were scheduled to undergo macular hole surgery and randomized to with and without internal limiting membrane (ILM) peeling

Description

Inclusion Criteria:

  • Eligible participants are those with idiopathic FTMH in stages 2-3, of less or equal than 18 months duration (based on symptoms reported by the patient) and with a visual acuity equal to or worse than 20/40 in the study eye.

Exclusion Criteria:

  • Patients with idiopathic FTMH stages 2-3 but longer than 18 months duration or with other causes of decreased vision (e.g. corneal scarring, age-related macular degeneration, diabetic retinopathy, glaucoma if central and/or paracentral absolute visual field defects are present) and
  • Those with FTMH related to high myopia (> 6 dioptres) or trauma will be excluded from the study.

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

Cohorts and Interventions

Group / Cohort
ILM-on group
patients were scheduled to undergo macular hole surgery without internal limiting membrane (ILM) peeling
ILM-off group
patients were scheduled to undergo macular hole surgery with internal limiting membrane (ILM) peeling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anatomic Success rate
Time Frame: 12 months
Anatomic success defined as a closed hole without a visible edge or a flat hole without a rim of subretinal fluid.
12 months
Functional Success Rate
Time Frame: 12 month
Functional Success defined as an improvement of 2 or more Snellen BCVA.
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best-corrected visual acuity
Time Frame: 12 month
All Snellen BCVA were converted to logarithm of the minimum angle of resolution (logMAR) BCVA
12 month
Complications
Time Frame: 12 months
Such as elevated intraocular pressure,retinal tear,rhegmatogenous retinal detachment
12 months

Collaborators and Investigators

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

Sponsor

Yifan Feng

Collaborators

Wenzhou Medical University

Investigators

  • Principal Investigator: Yifan Feng, MD, Wenzhou Medical 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

January 1, 2013

Primary Completion (ANTICIPATED)

April 1, 2014

Study Completion (ANTICIPATED)

May 1, 2014

Study Registration Dates

First Submitted

September 13, 2012

First Submitted That Met QC Criteria

September 18, 2012

First Posted (ESTIMATE)

September 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 13, 2014

Last Update Submitted That Met QC Criteria

February 12, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F20120913

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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