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

This study is currently recruiting participants.
Verified February 2014 by Wenzhou Medical University
Sponsor:
Collaborator:
Wenzhou Medical University
Information provided by (Responsible Party):
Yifan Feng, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT01687829
First received: September 13, 2012
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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
Macular Holes

Study Type: Observational
Study Design: 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

Further study details as provided by Wenzhou Medical University:

Primary Outcome Measures:
  • Anatomic Success rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Anatomic success defined as a closed hole without a visible edge or a flat hole without a rim of subretinal fluid.

  • Functional Success Rate [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Functional Success defined as an improvement of 2 or more Snellen BCVA.


Secondary Outcome Measures:
  • Best-corrected visual acuity [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    All Snellen BCVA were converted to logarithm of the minimum angle of resolution (logMAR) BCVA

  • Complications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Such as elevated intraocular pressure,retinal tear,rhegmatogenous retinal detachment


Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 13, 2012
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014