Full thickness macular hole and Internal Limiting Membrane (ILM) peeling Study: a randomised comparison of macular hole surgery with or without internal limiting membrane peeling

Not Applicable

Completed

• Conditions: Full-thickness macular holes in the centre of the retina; Eye Diseases; Macular hole

• Registration Number: ISRCTN33175422
• Lead Sponsor: niversity of Aberdeen (UK)

Brief Summary

1. 2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18980675 2. 2011 results in https://www.ncbi.nlm.nih.gov/pubmed/21051731

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-21
• Study Completion: 2008-05-31
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Patients with idiopathic full-thickness macular holes (FTMHs) stages 2-3 of equal to or less than 18 months duration and with vision equal to or worse than 20/40 in the study eye.

Exclusion Criteria

Patients with macular holes of stage 1 or 4 or with a hole of greater than 18 months duration will be excluded. If the FTMH is related to high myopia or trauma or there are 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) will also be excluded. Patients who are unable to understand English or give informed consent to be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distance visual acuity at 6 months post surgery.

Secondary Outcome Measures

Name	Time	Method
Distance visual acuity at 3 months, near visual acuity at 3 and 6 months, contrast sensitivity at 6 months, reading speed at 6 months, health related quality of life, costs to the health service and the participant, incremental costs per QALY and adverse events.