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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN33175422
Enrollment
150
Registered
2005-09-21
Start date
2005-06-01
Completion date
Unknown
Last updated
2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Full-thickness macular holes in the centre of the retina Eye Diseases Macular hole

Interventions

Participants will undergo one of the two possible macular hole surgeries: 1. Surgery without ILM peeling 2. Surgery with ILM peeling

Sponsors

University of Aberdeen (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Distance visual acuity at 6 months post surgery.

Secondary

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026