Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty

Fuchs' Endothelial Dystrophy Clinical Trial

— SUPER-DMEK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05399095
• Other study ID #: ETK 22-1101
• Status: Completed
• Phase: N/A
• Start date: May 23, 2022
• Est. completion date: May 23, 2023

Study information

• Verified date: July 2023
• Source: University Eye Hospital, Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 23, 2023
• Est. primary completion date: May 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Fuchs' Endothelial Dystrophy

Intervention

Behavioral:
• Supine positioning: 5 days
Supine positioning for 5 days after DMEK
• Supine positioning: 1 days
Supine positioning for 1 days after DMEK

Locations

Country	Name	City	State
Germany	Medical Center - University of Freiburg, Eye Hospital	Freiburg	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Eye Hospital, Freiburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Rebubbling	Number of eyes with secondary injection of air after DMEK	At two weeks and 3 months after DMEK
Secondary	Safety of supine positioning	Adverse events (AE) and serious AEs (SAE)	At two weeks and 3 months after DMEK
Secondary	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
Secondary	Visual acuity	Best-corrected visual acuity to determine visual acuity in letters	At 3, 12, and 24 months after DMEK
Secondary	Disability glare	Straylight meter measurement to determine forward scatter in logs straylight parameter	At 3, 12, and 24 months after DMEK
Secondary	Graft health: endothelial cell density	Specular microscopy to determine endothelial cell density	At 3, 12, and 24 months after DMEK
Secondary	Graft health	Slit-lamp exam to identify signs of graft rejection	At 12, and 24 months after DMEK
Secondary	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
Secondary	Corneal edema	Tomography to determine corneal edema in µm	At 2 weeks and at 3, 12, and 24 months after DMEK
Secondary	Corneal backscatter	Tomography to determine corneal backscatter in scatter units (SU)	At 3, 12, and 24 months after DMEK