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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Page 1 of 2 (7 locations)

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