An interventional study of Air and 10% SF6 and 90% air in Macular Holes and Optical Coherence Tomography, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by Medical University of Graz · Not applicable, Interventional, and Treatment
State of the art treatment for idiopathic macular holes consists of pars plana vitrectomy, internal limiting membrane staining with a blue colouring dye, internal limiting membrane peeling and filling of the vitrectomized space with a specific tamponade such as air and SF6. Air and SF6 have previously shown similar closure rates, although there was a trend towards lower closure rates in large diameter IMH (Idiopathic Macular Holes) using air. IMH with diameters \< 600 μm are currently believed to have similar closure rates with air and SF6. The investigators want to assess possible effects of the used tamponade (air or SF6) on closure rates and perfusion parameters represented by OCTA (Optical coherence tomography angiography). IMH eyes with a minimum diameter > 600 μm will be excluded. Two idiopathic macular hole patient groups will therefore be formed: The first group (group 1) will receive air after vitrectomy and membrane peeling, the second group (group 2) will receive 10% SF6 (and 90% air) after vitrectomy and membrane peeling. After recruitment, patients will therefore be electronically randomized to one of the two groups. The groups will then be compared by the means of OCT (Optical coherence tomography) and OCTA.
Note: The trial was registered retrospectively on Clinicaltrials.gov after start of recruitment.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.
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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.
Air tamponade after vitrectomy.
Procedure: Air
10% SF6 tamponade after vitrectomy.
Procedure: 10% SF6 and 90% air
Test if air is sufficient for macular hole closure.
Test if 10% SF6 and 90% air is sufficient for macular hole closure.
Macular hole closure
Time frame: 2 weeks
Foveal avascular zone area
Time frame: 3 months
Parafoveal vessel density
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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