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NCT Number: NCT06211907

Small Macular Holes Treated With Air

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

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Key information

Conditions

Macular Holes Eye Diseases Retinal Diseases Retinal Perforations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, University of Thessaly, Thessaly, Greece

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative intraocular tamponade

Device

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

Primary outcomes

  1. Macular hole closure after single surgery

    Time frame: 4 weeks

    Closure verified on OCT

Secondary outcomes

  1. Change in outcome of patient well-being

    Time frame: 4 weeks and 4 months

    Questionnaire

  2. Change in visual acuity i ETDRS lines

    Time frame: 4 weeks and 4 months

    Early Treatment of Diabetic Retinopathy Score in logMAR. Higher scores mean a worse outcome

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Collaborators

  • Bangor University, Qwynedd, UK
  • Haukeland University Hospital
  • McGill University
  • Oslo University Hospital, Oslo, Norway
  • Royal Liverpool University Hospital
  • St. Olavs Hospital
  • University Hospital Complex of Santiago de Compostela, Galicia, Spain
  • University Hospital of North Norway
  • University of Stavanger

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 18, 2024
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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