Full-thickness macular holes in the centre of the retina Eye Diseases Macular hole
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Distance visual acuity at 6 months post surgery. | — |
Secondary
| Measure | Time 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