Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty

NCT05399095 | Completed DMC

• 1 other identifier: ETK 22-1101
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (2)

• Graft attachment

  Area of graft detachment, quantified from a trained and validated neural network for image segmentation of anterior segment optical coherence tomography

  At two weeks after DMEK

• Graft attachment

  Volume of graft detachment, quantified from a trained and validated neural network for image segmentation of anterior segment optical coherence tomography

  At two weeks after DMEK

Secondary Outcomes (10)

• Rebubbling

  At two weeks and 3 months after DMEK

• Safety of supine positioning

  At two weeks and 3 months after DMEK

• Subjective visual function

  At 3, 12, and 24 months after DMEK

• Visual acuity

  At 3, 12, and 24 months after DMEK

• Disability glare

  At 3, 12, and 24 months after DMEK

Study Arms (2)

5 days supine positioning

EXPERIMENTAL

Supine positioning for 5 days after DMEK with upright positioning for only 10 min every hour.

Behavioral: Supine positioning: 5 days

1 day supine positioning followed by usual physical activity for 4 days

ACTIVE COMPARATOR

Supine positioning for 1 days after DMEK with upright positioning for only 10 min every hour.

Behavioral: Supine positioning: 1 days

Interventions

Supine positioning: 5 days BEHAVIORAL

Supine positioning for 5 days after DMEK

5 days supine positioning

Supine positioning: 1 days BEHAVIORAL

Supine positioning for 1 days after DMEK

1 day supine positioning followed by usual physical activity for 4 days

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Eye Hospital, Freiburg: lead

Study Sites (1)

Medical Center - University of Freiburg, Eye Hospital

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Katrin Wacker, MD FEBO

  University of Freiburg, Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, surgeons, and investigators will be masked until the first postoperative day after DMEK. Investigators will open the opaque envelope with the study assignment together with the participant and inform care providers on the positioning regimen for the next 4 days. The primary outcome will be assessed by a masked investigator using a trained and validated neural network for image segmentation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2022
• First Posted: June 1, 2022
• Study Start: May 23, 2022
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)