We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01687829
Recruitment Status : Unknown
Verified February 2014 by Yifan Feng, Wenzhou Medical University.
Recruitment status was:  Recruiting
First Posted : September 19, 2012
Last Update Posted : February 13, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Macular Holes

Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Macular Hole Surgery With and Without Internal Limiting Membrane Peeling:A Systematic Review and Meta-analysis
Study Start Date : January 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : May 2014
Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. Functional Success Rate [ Time Frame: 12 month ]
    Functional Success defined as an improvement of 2 or more Snellen BCVA.


Secondary Outcome Measures :
  1. Best-corrected visual acuity [ Time Frame: 12 month ]
    All Snellen BCVA were converted to logarithm of the minimum angle of resolution (logMAR) BCVA

  2. Complications [ Time Frame: 12 months ]
    Such as elevated intraocular pressure,retinal tear,rhegmatogenous retinal detachment


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687829


Locations
China, Zhejiang
Wenzhou Medical College Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Yifan Feng, MD    +86-577-88068880    wzafengyifan@163.com   
Principal Investigator: Yifan Feng, MD         
Sponsors and Collaborators
Yifan Feng
Wenzhou Medical University
Investigators
Principal Investigator: Yifan Feng, MD Wenzhou Medical University
More Information

Responsible Party: Yifan Feng, Eye Hospital, Wenzhou Medical College, China, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01687829     History of Changes
Other Study ID Numbers: F20120913
First Posted: September 19, 2012    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014

Keywords provided by Yifan Feng, Wenzhou Medical University:
Macular Holes
Internal limiting membrane
peeling
Surgery

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases