Clinical trial Recruiting at 6 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment132 (estimated)
SponsorHelse Stavanger HF
Government
Locations7 sites (Thessaly, Thessaly and 6 other locations)
StatusRecruiting
StartedJuly 14, 2024
Main results expectedJune 30, 2028
Study endsJune 30, 2028
Registry record updatedNovember 6, 2024
Trial IDNCT06211907 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

  • 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
  • Department of Ophthalmology, University of Thessaly
    Thessaly, Thessaly, Greece
    Not yet recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.