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

• Sponsor: University Eye Hospital, Freiburg (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05399095
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 37.3
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Fuchs' Endothelial Dystrophy	Behavioral: Supine positioning: 5 days; Behavioral: Supine positioning: 1 days	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty: a Randomized Controlled Trial
• Anticipated Study Start Date: May 23, 2022
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jun 30, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Graft attachment [At two weeks after DMEK]

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

2. Graft attachment [At two weeks after DMEK]

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

Secondary Outcome Measures

1. Rebubbling [At two weeks and 3 months after DMEK]

   Number of eyes with secondary injection of air after DMEK

2. Safety of supine positioning [At two weeks and 3 months after DMEK]

   Adverse events (AE) and serious AEs (SAE)

3. Subjective visual function [At 3, 12, and 24 months after DMEK]

   Subjective visual function on a scale from 0 (worse vision) to 10 (best vision) with higher scores meaning better subjective visual function

4. Visual acuity [At 3, 12, and 24 months after DMEK]

   Best-corrected visual acuity to determine visual acuity in letters

5. Disability glare [At 3, 12, and 24 months after DMEK]

   Straylight meter measurement to determine forward scatter in logs straylight parameter

6. Graft health: endothelial cell density [At 3, 12, and 24 months after DMEK]

   Specular microscopy to determine endothelial cell density

7. Graft health [At 12, and 24 months after DMEK]

   Slit-lamp exam to identify signs of graft rejection

8. Patient-reported visual disability [At 3, 12, and 24 months after DMEK]

   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.

9. Corneal edema [At 2 weeks and at 3, 12, and 24 months after DMEK]

   Tomography to determine corneal edema in µm

10. Corneal backscatter [At 3, 12, and 24 months after DMEK]

    Tomography to determine corneal backscatter in scatter units (SU)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Center - University of Freiburg, Eye Hospital	Freiburg	Baden-Wuerttemberg	Germany	79106

Sponsors and Collaborators

• University Eye Hospital, Freiburg

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Eye Hospital, Freiburg
• ClinicalTrials.gov Identifier: NCT05399095
• Other Study ID Numbers: ETK 22-1101
• First Posted: Jun 1, 2022
• Last Update Posted: Jun 3, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Eye Hospital, Freiburg: 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
• Additional relevant MeSH terms: Fuchs' Endothelial Dystrophy

Study Results

No Results Posted as of Jun 3, 2022