Topic: Ophthalmology
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Presence of idiopathic full-thickness macular hole, greater than or equal to 400 µm in diameter as measured OCT 2. Patients electing to have surgery for macular hole, with or without simultaneous phacoemulsification and intra-ocular lens implant 3. Ability and willingness to position face-down or in an inactive faceforward position 4. Lower age limit 18 years
Exclusion criteria
Exclusion criteria: 1. Age-related macular degeneration; glaucoma; diabetic retinopathy; retinal degeneration; amblyopia; previous vitrectomy surgery (refractive error, lens opacity and previous use of ocriplasmin are not exclusion criteria) 2. Traumatic macular hole 3. History of visual loss suggesting macular hole duration longer than 12 months 4. Presence of a retinal tear identified during surgery for which post operative positioning is advised
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anatomical closure of the macular hole; Timepoint(s): Determined at three months after surgery by masked assessment of OCT scans. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the impact of face-down positioning on sight, quality of life and wellbeing. | — |
Countries
United Kingdom