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

Macular Holes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01687829
• Other study ID #: F20120913
• Status: Recruiting
• Phase: N/A
• First received: September 13, 2012
• Last updated: February 12, 2014
• Start date: January 2013
• Est. completion date: May 2014

Study information

• Verified date: February 2014
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Locations

Country	Name	City	State
China	Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Yifan Feng	Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Functional Success Rate	Functional Success defined as an improvement of 2 or more Snellen BCVA.	12 month	No
Secondary	Best-corrected visual acuity	All Snellen BCVA were converted to logarithm of the minimum angle of resolution (logMAR) BCVA	12 month	No
Secondary	Complications	Such as elevated intraocular pressure,retinal tear,rhegmatogenous retinal detachment	12 months	No