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

Primary Purpose

Fuchs' Endothelial Dystrophy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Supine positioning: 5 days
Supine positioning: 1 days
Sponsored by
University Eye Hospital, Freiburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fuchs' Endothelial Dystrophy focused on measuring 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

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Center - University of Freiburg, Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

5 days supine positioning

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rebubbling
Number of eyes with secondary injection of air after DMEK
Safety of supine positioning
Adverse events (AE) and serious AEs (SAE)
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
Visual acuity
Best-corrected visual acuity to determine visual acuity in letters
Disability glare
Straylight meter measurement to determine forward scatter in logs straylight parameter
Graft health: endothelial cell density
Specular microscopy to determine endothelial cell density
Graft health
Slit-lamp exam to identify signs of graft rejection
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.
Corneal edema
Tomography to determine corneal edema in µm
Corneal backscatter
Tomography to determine corneal backscatter in scatter units (SU)

Full Information

First Posted
May 22, 2022
Last Updated
July 22, 2023
Sponsor
University Eye Hospital, Freiburg
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1. Study Identification

Unique Protocol Identification Number
NCT05399095
Brief Title
Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty
Acronym
SUPER-DMEK
Official Title
Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
May 23, 2023 (Actual)
Study Completion Date
May 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Eye Hospital, Freiburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5 days supine positioning
Arm Type
Experimental
Arm Description
Supine positioning for 5 days after DMEK with upright positioning for only 10 min every hour.
Arm Title
1 day supine positioning followed by usual physical activity for 4 days
Arm Type
Active Comparator
Arm Description
Supine positioning for 1 days after DMEK with upright positioning for only 10 min every hour.
Intervention Type
Behavioral
Intervention Name(s)
Supine positioning: 5 days
Intervention Description
Supine positioning for 5 days after DMEK
Intervention Type
Behavioral
Intervention Name(s)
Supine positioning: 1 days
Intervention Description
Supine positioning for 1 days after DMEK
Primary Outcome Measure Information:
Title
Graft attachment
Description
Area of graft detachment, quantified from a trained and validated neural network for image segmentation of anterior segment optical coherence tomography
Time Frame
At two weeks after DMEK
Title
Graft attachment
Description
Volume of graft detachment, quantified from a trained and validated neural network for image segmentation of anterior segment optical coherence tomography
Time Frame
At two weeks after DMEK
Secondary Outcome Measure Information:
Title
Rebubbling
Description
Number of eyes with secondary injection of air after DMEK
Time Frame
At two weeks and 3 months after DMEK
Title
Safety of supine positioning
Description
Adverse events (AE) and serious AEs (SAE)
Time Frame
At two weeks and 3 months after DMEK
Title
Subjective visual function
Description
Subjective visual function on a scale from 0 (worse vision) to 10 (best vision) with higher scores meaning better subjective visual function
Time Frame
At 3, 12, and 24 months after DMEK
Title
Visual acuity
Description
Best-corrected visual acuity to determine visual acuity in letters
Time Frame
At 3, 12, and 24 months after DMEK
Title
Disability glare
Description
Straylight meter measurement to determine forward scatter in logs straylight parameter
Time Frame
At 3, 12, and 24 months after DMEK
Title
Graft health: endothelial cell density
Description
Specular microscopy to determine endothelial cell density
Time Frame
At 3, 12, and 24 months after DMEK
Title
Graft health
Description
Slit-lamp exam to identify signs of graft rejection
Time Frame
At 12, and 24 months after DMEK
Title
Patient-reported visual disability
Description
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.
Time Frame
At 3, 12, and 24 months after DMEK
Title
Corneal edema
Description
Tomography to determine corneal edema in µm
Time Frame
At 2 weeks and at 3, 12, and 24 months after DMEK
Title
Corneal backscatter
Description
Tomography to determine corneal backscatter in scatter units (SU)
Time Frame
At 3, 12, and 24 months after DMEK

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrin Wacker, MD FEBO
Organizational Affiliation
University of Freiburg, Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center - University of Freiburg, Eye Hospital
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79106
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty

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