RecruitingNot ApplicableNCT06211907

Small Macular Holes Treated With Air

Small Macular Holes Treated With Air: A Prospective Randomized Controlled Multicenter Trial


Sponsor

Helse Stavanger HF

Enrollment

132 participants

Start Date

Jul 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Non-inferiority trial comparing intraocular air and gas tamponade for closure of macular holes.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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

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Interventions

DEVICEPostoperative intraocular tamponade

Flushing the eye cavity with a tamponade at the end of surgery


Locations(7)

Department of Ophthalmology, University of Thessaly

Thessaly, Thessaly, Greece

Stavanger University Hospital

Stavanger, Rogaland, Norway

University Hospital of Northern Norway

Tromsø, Troms, Norway

St. Olavs University Hospital

Trondheim, Tronderlag, Norway

Haukeland University Hospital

Bergen, Vestland, Norway

Oslo University Hospital

Oslo, Norway

Clinical Universitary Hospital of Santiago

Santiago de Compostela, La Coruna, Spain

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NCT06211907


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