Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty (SUPER-DMEK)

Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty: a Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Fuchs' Endothelial Dystrophy
• Intervention / Treatment: Behavioral: Supine positioning: 5 days; Behavioral: Supine positioning: 1 days

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Wuerttemberg
    • Freiburg, Baden-Wuerttemberg, Germany, 79106
      • Medical Center - University of Freiburg, Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5 days supine positioning; Supine positioning for 5 days after DMEK with upright positioning for only 10 min every hour.	Behavioral: Supine positioning: 5 days; Supine positioning for 5 days after DMEK
Active Comparator: 1 day supine positioning followed by usual physical activity for 4 days; Supine positioning for 1 days after DMEK with upright positioning for only 10 min every hour.	Behavioral: Supine positioning: 1 days; Supine positioning for 1 days after DMEK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rebubbling	Number of eyes with secondary injection of air after DMEK	At two weeks and 3 months after DMEK
Safety of supine positioning	Adverse events (AE) and serious AEs (SAE)	At two weeks and 3 months after DMEK
Subjective visual function	Subjective visual function on a scale from 0 (worse vision) to 10 (best vision) with higher scores meaning better subjective visual function	At 3, 12, and 24 months after DMEK
Visual acuity	Best-corrected visual acuity to determine visual acuity in letters	At 3, 12, and 24 months after DMEK
Disability glare	Straylight meter measurement to determine forward scatter in logs straylight parameter	At 3, 12, and 24 months after DMEK
Graft health: endothelial cell density	Specular microscopy to determine endothelial cell density	At 3, 12, and 24 months after DMEK
Graft health	Slit-lamp exam to identify signs of graft rejection	At 12, and 24 months after DMEK
Patient-reported visual disability	The Visual Acuity Factor and Glare Factor of the Visual Function and Corneal Health Status (V-FUCHS) instrument. The instrument's scores are Rasch-analysis based scores expressed in logits. Participants with more difficulty have higher or more positive V-FUCHS scores.	At 3, 12, and 24 months after DMEK
Corneal edema	Tomography to determine corneal edema in µm	At 2 weeks and at 3, 12, and 24 months after DMEK
Corneal backscatter	Tomography to determine corneal backscatter in scatter units (SU)	At 3, 12, and 24 months after DMEK

Collaborators and Investigators

• Sponsor: University Eye Hospital, Freiburg
• Investigators: Principal Investigator: Katrin Wacker, MD FEBO, University of Freiburg, Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Actual): May 23, 2023
• Study Completion (Actual): May 23, 2023

Study Registration Dates

• First Submitted: May 22, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 22, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Machine learning; Neural network; Anterior segment optical coherence tomography; Descemet membrane endothelial keratoplasty; Fuchs' endothelial corneal dystrophy; Incomplete graft attachment; Endothelial corneal graft detachment; Rebubbling (repeat injection of air or gas in the anterior chamber); Supine positioning; Postoperative posture
• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: ETK 22-1101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No