Treatment of small macular holes using air
Official title: Small Macular Holes Treated With Air: A Prospective Randomized Controlled Multicenter Trial
Run by Helse Stavanger HF · NCT06211907 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 132 (estimated) |
| Sponsor | Helse Stavanger HF Government |
| Locations | 7 sites (Thessaly, Thessaly and 6 other locations) |
| Status | Recruiting |
| Started | July 14, 2024 |
| Main results expected | June 30, 2028 |
| Study ends | June 30, 2028 |
| Registry record updated | November 6, 2024 |
| Trial ID | NCT06211907 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success with gas tamponade for macular hole closure, but the use of air is less commonly tested.
Who can join: the full rules
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 it's running
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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
Show 1 more location
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Department of Ophthalmology, University of Thessaly
Thessaly, Thessaly, Greece Not yet recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.