Bullous Keratopathy, Fuchs' Endothelial Dystrophy
Conditions
Keywords
Intraocular gas, Positioning, DMEK, Endothelial keratoplasty
Brief summary
This blinded, randomized study compares the use of air and sulfur hexaflouride (SF6) tamponade in Descemet Membrane Endothelial Keratoplasty.
Interventions
PROCEDUREIntraocular gas
Participants randomized to either air or SF6 gas in the anterior chamber.
Sponsors
Glostrup University Hospital, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Surgeon and patient masked to choice of intraocular gas. Study coordinator not masked.
Intervention model description
Patients randomized to either air or sulfur hexafluoride (SF6)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Eligible for DMEK surgey
Exclusion criteria
Related to ocular health * Re-DMEK or prior penetrating keratoplasty * Ocular hypertension resistant to topical medication * Previous vitrectomy * Minimally invasive glaucoma devices * Aphakia * Anterior chamber or iris claw lens * Implantable Collamer Lens (ICL) * Clinically significant corneal scarring * Central corneal thickness \>750 µm * BCVA \< 0.1 Related to general health * Not able to give informed consent * Inability to position correctly due to organic or psychological condition. Related to surgical procedure * Graft diameter \>9 mm or \< 7mm * Graft central endothelial cell count \< 2000 cells/mm2 * Graft unfolding duration \>1 hour * Graft morphology grade 4-5 * Significant graft decentration (graft contour not visible in microscope) * Significant presence of Descemet remnants in the graft-host interface * Presence of inward folds * Graft 'stroma-surface' placed facing away from recipient stroma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft detachment | Occurence within 3 months postoperative | Significant graft detachment: 1/3 of graft and affecting visual function. Measured by OCT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | 3 months postoperative | Snellen chart (logMAR) |
| Gas fill | Serial measurements during postoperative week 1. | Postoperative gas fill measured by OCT. |
| Positioning | 72 hours postoperative | Pitch and roll of head using positioning device |
| Complications | Occurence within 3 months postoperative | Any adverse outcome affecting the eye |
Countries
Denmark
Contacts
Primary ContactMark Alberti, MD
Outcome results
None listed