An interventional study of Intraocular gas in Fuchs' Endothelial Dystrophy and Bullous Keratopathy, sponsored by Glostrup University Hospital, Copenhagen. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by Glostrup University Hospital, Copenhagen · Not applicable, Interventional, and Treatment
This blinded, randomized study compares the use of air and sulfur hexaflouride (SF6) tamponade in Descemet Membrane Endothelial Keratoplasty.
92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.
This study's planned enrollment of 104 is above the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.
Browse Fuchs' Endothelial Dystrophy studies →Glostrup University Hospital, Copenhagen is the lead sponsor of 106 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Related to ocular health
Related to general health
Related to surgical procedure
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Intraocular 100% atmospheric air (anterior chamber).
Procedure: Intraocular gas
Intraocular 20% sulphur hexaflouride (anterior chamber).
Procedure: Intraocular gas
Participants randomized to either air or SF6 gas in the anterior chamber.
Graft detachment
Significant graft detachment: 1/3 of graft and affecting visual function. Measured by OCT.
Time frame: Occurence within 3 months postoperative
Visual acuity
Snellen chart (logMAR)
Time frame: 3 months postoperative
Gas fill
Postoperative gas fill measured by OCT.
Time frame: Serial measurements during postoperative week 1.
Positioning
Pitch and roll of head using positioning device
Time frame: 72 hours postoperative
Complications
Any adverse outcome affecting the eye
Time frame: Occurence within 3 months postoperative
Plan to share: Undecided — If permitted by the Danish Data Protection Agency
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Fuchs' Endothelial Dystrophy →
Glostrup University Hospital, Copenhagen →