Small Macular Holes Treated With Air
ConditionMacular Holes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelse Stavanger HF
About this trial
Non-inferiority trial comparing intraocular air and gas tamponade for closure of macular holes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary MH ≤250 μm
MH duration ≤12 months
No previous vitreoretinal surgery in study eye
Ability to sign informed consent
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Postoperative intraocular tamponade
DeviceFlushing the eye cavity with a tamponade at the end of surgery
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: Gas tamponadeActive comparator 1 intervention
Group B: Air tamponadeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Macular hole closure after single surgery
Closure verified on OCT
Time frame
4 weeksSecondary outcomes
1
Change in outcome of patient well-being
Questionnaire
Time frame
4 weeks and 4 months2
Change in visual acuity i ETDRS lines
Early Treatment of Diabetic Retinopathy Score in logMAR. Higher scores mean a worse outcome
Time frame
4 weeks and 4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Helse Stavanger HF
Lead sponsor
Haukeland University Hospital
Collaborator
St. Olavs Hospital
Collaborator
Oslo University Hospital, Oslo, Norway
Collaborator
University Hospital of North Norway
Collaborator
University of Stavanger
Collaborator
Royal Liverpool University Hospital
Collaborator
Bangor University, Qwynedd, UK
Collaborator
McGill University
Collaborator
University Hospital Complex of Santiago de Compostela, Galicia, Spain
Collaborator
Source ClinicalTrials.gov