Clinical trial NCT05399095: Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty
Official title: Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fuchs' Endothelial Dystrophy
Keywords: Fuchs' endothelial corneal dystrophy
Descemet membrane endothelial keratoplasty
Incomplete graft attachment
Endothelial corneal graft detachment
Rebubbling (repeat injection of air or gas in the anterior chamber)
Supine positioning
Postoperative posture
Anterior segment optical coherence tomography
Neural network
Machine learning
Randomized controlled trial
Lead sponsor: University Eye Hospital, Freiburg
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stratification will be performed according to the surgical procedure (DMEK alone or DMEK combined cataract surgery). Within each strata, participants will be randomized in a 1:1 ratio to 5 days (intervention) and 1 day (control) postoperative supine positioning.
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial evaluates the efficacy and safety of postoperative supine head positioning on graft attachment after Descemet membrane endothelial keratoplasty in patients with Fuchs' endothelial corneal dystrophy (FECD).

Detailed description: In Descemet membrane endothelial keratoplasty (DMEK), an air or gas bubble is inserted in the anterior chamber of the eye to keep the ultrathin endothelial corneal graft attached to the patients own cornea. Supine positioning is thought to improve attachment by using the tamponade effect of the bubble. At present, it is unclear how long supine positioning is required. Positioning regimens vary between one hour to over one week. In this trial, the investigators will assess if prolonged supine positioning for 5 days improves graft attachment and long-term outcomes compared to supine positioning for 1 day.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of advanced Fuchs' endothelial corneal dystrophy (FECD)
* Indication for corneal endothelial transplantation (Descemet Membrane Endothelial Keratoplasty - DMEK)

Exclusion Criteria:

* Other corneal diseases (i.e. corneal scars, corneal dystrophies except FECD, corneal inflammation / infection)
* Regular use of drugs potentially affecting the cornea (i.e. amiodarone, chloroquine, triptan, isotretinoin, use of contact lenses in past four weeks, anesthetic eye drops)
* Diabetes mellitus with endorgan complications)
* Lack of fixation during corneal tomography
* Bedridden

Primary outcomes:
measure: Graft attachment
timeFrame: At two weeks after DMEK
measure: Graft attachment
timeFrame: At two weeks after DMEK
Secondary outcomes:
measure: Rebubbling
timeFrame: At two weeks and 3 months after DMEK
measure: Safety of supine positioning
timeFrame: At two weeks and 3 months after DMEK
measure: Subjective visual function
timeFrame: At 3, 12, and 24 months after DMEK
measure: Visual acuity
timeFrame: At 3, 12, and 24 months after DMEK
measure: Disability glare
timeFrame: At 3, 12, and 24 months after DMEK
measure: Graft health: endothelial cell density
timeFrame: At 3, 12, and 24 months after DMEK
measure: Graft health
timeFrame: At 12, and 24 months after DMEK
measure: Patient-reported visual disability
timeFrame: At 3, 12, and 24 months after DMEK
measure: Corneal edema
timeFrame: At 2 weeks and at 3, 12, and 24 months after DMEK
measure: Corneal backscatter
timeFrame: At 3, 12, and 24 months after DMEK
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Medical Center - University of Freiburg, Eye Hospital
state: Baden-Wuerttemberg
Study officials:
affiliation: University of Freiburg, Eye Hospital
name: Katrin Wacker, MD FEBO
role: PRINCIPAL_INVESTIGATOR
References: