Status:
RECRUITING
Small Macular Holes Treated With Air
Lead Sponsor:
Helse Stavanger HF
Collaborating Sponsors:
Haukeland University Hospital
St. Olavs Hospital, Trondheim, Norway
Conditions:
Macular Holes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Non-inferiority trial comparing intraocular air and gas tamponade for closure of macular holes.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06211907
Start Date
July 14 2024
End Date
June 30 2028
Last Update
November 6 2024
Active Locations (7)
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1
Department of Ophthalmology, University of Thessaly
Thessaly, Thessaly, Greece, 38221
2
Stavanger University Hospital
Stavanger, Rogaland, Norway, 4026
3
University Hospital of Northern Norway
Tromsø, Troms, Norway, 9019
4
St. Olavs University Hospital
Trondheim, Tronderlag, Norway, 7030