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

NCT01687829 | Unknown

• 1 other identifier: F20120913
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Holes

Keywords

Macular Holes; Internal limiting membrane; peeling; Surgery

Outcome Measures

Primary Outcomes (2)

• Anatomic Success rate

  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

  Functional Success defined as an improvement of 2 or more Snellen BCVA.

  12 month

Secondary Outcomes (2)

• Best-corrected visual acuity

  12 month

• Complications

  12 months

Study Arms (2)

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 Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yifan Feng: lead
• Wenzhou Medical University: collaborator

Study Sites (1)

Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Yifan Feng, MD

  Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Eye Hospital, Wenzhou Medical College, China

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: September 19, 2012
• Study Start: January 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 13, 2014

Record last verified: 2014-02

Locations

CN (1)