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

• Conditions: Macular Holes

• Registration Number: NCT01687829
• Lead Sponsor: Yifan Feng

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-19
• Study Start: 2013-01
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-12
• Last Update Posted: 2014-02-13
• Primary Completion: 2014-04
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China