Treatment of small macular holes using air
Small Macular Holes Treated With Air: A Prospective Randomized Controlled Multicenter Trial
This study tests whether using air instead of gas during surgery can help close small macular holes in the eyes for patients who have had them for less than a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Helse Stavanger HF Government |
| Locations | 7 sites (Thessaly, Thessaly and 6 other locations) |
| Trial ID | NCT06211907 on ClinicalTrials.gov |
What this trial studies
This trial compares the effectiveness of intraocular air versus gas tamponade in closing small macular holes. It focuses on patients with primary macular holes that are less than or equal to 250 μm in size and have been present for no longer than 12 months. Participants will undergo a surgical procedure where postoperative intraocular tamponade is applied to facilitate closure of the macular hole. The study aims to determine if air is as effective as gas in achieving closure.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with primary macular holes of 250 μm or less and a duration of 12 months or less.
Not a fit: Patients with previous vitreoretinal surgery in the study eye or those with secondary macular holes due to other conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with small macular holes.
How similar studies have performed: Other studies have shown success with gas tamponade for macular hole closure, but the use of air is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Thessaly, Thessaly and 6 other locations
- Department of Ophthalmology, University of Thessaly — Thessaly, Thessaly, Greece (Not_yet_recruiting)
- Stavanger University Hospital — Stavanger, Rogaland, Norway (Recruiting)
- University Hospital of Northern Norway — Tromsø, Troms, Norway (Recruiting)
- St. Olavs University Hospital — Trondheim, Tronderlag, Norway (Recruiting)
- Haukeland University Hospital — Bergen, Vestland, Norway (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- Clinical Universitary Hospital of Santiago — Santiago de Compostela, La Coruna, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.