Macular Holes
Conditions
Brief summary
Non-inferiority trial comparing intraocular air and gas tamponade for closure of macular holes.
Interventions
DEVICEPostoperative intraocular tamponade
Flushing the eye cavity with a tamponade at the end of surgery
Sponsors
Haukeland University Hospital
St. Olavs Hospital, Trondheim, Norway
Oslo University Hospital, Oslo, Norway
University Hospital of Northern Norway, Tromsø, Norway
University of Stavanger
Royal Liverpool University Hospital
Bangor University, Qwynedd, UK
McGill University
University Hospital Complex of Santiago de Compostela, Galicia, Spain
Helse Stavanger HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Non-inferiority Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary MH ≤250 μm * MH duration ≤12 months * No previous vitreoretinal surgery in study eye * Ability to sign informed consent * Signed informed consent * Age ˃18 years
Exclusion criteria
* Previous vitreoretinal surgery in study eye * Secondary MH caused by other conditions than vitreomacular traction * Myopic MH, i.e., excessive myopia (more than -6 dioptres) * Traumatic MH * MH secondary to retinal detachment or other retinal diseases * Previously participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Macular hole closure after single surgery | 4 weeks | Closure verified on OCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in outcome of patient well-being | 4 weeks and 4 months | Questionnaire |
| Change in visual acuity i ETDRS lines | 4 weeks and 4 months | Early Treatment of Diabetic Retinopathy Score in logMAR. Higher scores mean a worse outcome |
Countries
Greece, Norway, Spain
Outcome results
None listed