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Completed

NCT Number: NCT05399095

Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty

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).

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Key information

Conditions

Fuchs' Endothelial Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Center - University of Freiburg, Eye Hospital

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supine positioning: 5 days

Behavioral

Supine positioning for 5 days after DMEK

Supine positioning: 1 days

Behavioral

Supine positioning for 1 days after DMEK

Primary outcomes

  1. Graft attachment

    Time frame: 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

    Time frame: 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 outcomes

  1. Rebubbling

    Time frame: At two weeks and 3 months after DMEK

    Number of eyes with secondary injection of air after DMEK

  2. Safety of supine positioning

    Time frame: At two weeks and 3 months after DMEK

    Adverse events (AE) and serious AEs (SAE)

  3. Subjective visual function

    Time frame: 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

    Time frame: At 3, 12, and 24 months after DMEK

    Best-corrected visual acuity to determine visual acuity in letters

  5. Disability glare

    Time frame: 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

    Time frame: At 3, 12, and 24 months after DMEK

    Specular microscopy to determine endothelial cell density

  7. Graft health

    Time frame: At 12, and 24 months after DMEK

    Slit-lamp exam to identify signs of graft rejection

  8. Patient-reported visual disability

    Time frame: 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

    Time frame: At 2 weeks and at 3, 12, and 24 months after DMEK

    Tomography to determine corneal edema in µm

  10. Corneal backscatter

    Time frame: At 3, 12, and 24 months after DMEK

    Tomography to determine corneal backscatter in scatter units (SU)

Sponsors and collaborators

Lead sponsor

University Eye Hospital, Freiburg

Other

Registry information

Official study title

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

Acronym: SUPER-DMEK

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2022
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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