Recruiting NCT06211907
Small Macular Holes Treated With Air
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Postoperative intraocular tamponade.
- Who it may be relevant to
- Registry conditions: Macular Holes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece, Norway, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Small Macular Holes Treated With Air: A Prospective Randomized Controlled Multicenter Trial
Overview
Non-inferiority trial comparing intraocular air and gas tamponade for closure of macular holes.
Interventions
- Device Postoperative intraocular tamponade
Flushing the eye cavity with a tamponade at the end of surgery
Primary outcome measures
- Macular hole closure after single surgery [Time frame: 4 weeks]
Secondary outcome measures (2)
- Change in outcome of patient well-being [Time frame: 4 weeks and 4 months]
- Change in visual acuity i ETDRS lines [Time frame: 4 weeks and 4 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Norway · 5 centers
- Stavanger University Hospital — Stavanger
- University Hospital of Northern Norway — Tromsø
- St. Olavs University Hospital — Trondheim
- Haukeland University Hospital — Bergen
- Oslo University Hospital — Oslo
Greece · 1 center
- Department of Ophthalmology, University of Thessaly — Thessaly
Spain · 1 center
- Clinical Universitary Hospital of Santiago — Santiago de Compostela
Identifiers
NCT: NCT06211907 · REK 580226