An interventional study of Postoperative intraocular tamponade in Macular Holes, sponsored by Helse Stavanger HF. Recruiting at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by Helse Stavanger HF · Not applicable, Interventional, and Treatment
Non-inferiority trial comparing intraocular air and gas tamponade for closure of macular holes.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's planned enrollment of 132 is above the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →Helse Stavanger HF is the lead sponsor of 97 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravitreal gas tamponade
Device: Postoperative intraocular tamponade
Intravitreal Air tamponade
Device: Postoperative intraocular tamponade
Flushing the eye cavity with a tamponade at the end of surgery
Macular hole closure after single surgery
Closure verified on OCT
Time frame: 4 weeks
Change in outcome of patient well-being
Questionnaire
Time frame: 4 weeks and 4 months
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 months
Started Jul 2024 (actual). Primary completion is estimated for Jun 2028, 47 months after the start.
Of 45 non-industry interventional studies with no phase under Retinal Perforations, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's planned 47 months is above that.
Counting every sponsor, half of 45 studies reached it within 28 months; a quarter within 12 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Helse Stavanger HF