Endothelial Side Up Inverted Femtosecond Laser Assisted DSAEK
1 other identifier
interventional
15
1 country
1
Brief Summary
To evaluate the clinical outcomes (pos toperative best corrected visual acuity, endothelial count) and anatomical results (interface smoothness) of DSAEK with Femto LDV-prepared grafts from the endothelial side.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 22, 2024
CompletedFirst Posted
Study publicly available on registry
October 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedOctober 22, 2024
August 1, 2024
2.9 years
August 22, 2024
October 18, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Best spectacle-corrected visual acuity
Measurement Tool: Snellen chart Unit of Measure: LogMAR
after 3 and 6 months
Endothelial cell count using specular microscopy
Measurement Tool: Specular microscopy Time Frame: After 3 months and 6 months
after 3 and 6 months
Secondary Outcomes (2)
Total central corneal thickness (CCT)
after 3 and 6 months
Donor Corneal Endothelial Thickness (CET)
After 3 months and 6 months
Study Arms (1)
Inverted DSAEK
EXPERIMENTALInterventions
The Femto LDV Z8 laser system will be set to create a 100 μm thick graft with a 7.5 mm diameter. The graft will be inverted, placed endothelial side up in the anterior chamber, and coated with Viscoat. A fixation ring will center the graft by holding the scleral rim with forceps. After cutting, the cornea should remain endothelium-up, stained with Trypan Blue, and dissected using a blunt spatula. The graft will be placed on a Busin glide and coated with Viscoat. A 3-4 mm corneal incision will be made, and Descemet's membrane will be marked and stripped. The graft will be inserted using the Busin glide, spreading automatically. A small air bubble will fill the anterior chamber to compress the graft for 10 minutes.
Eligibility Criteria
You may qualify if:
- Patients with Fuchs' endothelial dystrophy Patients with bullous keratopathy secondary to intraocular surgeries, iridocorneal endothelial syndrome, or viral keratitis
You may not qualify if:
- Bullous keratopathy secondary to glaucoma or ocular trauma Corneal stromal scarring or opacities Diseases not affecting the corneal endothelium, including corneal ectasia (e.g., keratoconus, keratoglobus, pellucid marginal degeneration) Epithelial, Bowman layer/anterior stromal, and stromal dystrophies Hypotonic eyes Retinal diseases Any type of optic atrophy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dar el Oyoun
Giza, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Associate
Study Record Dates
First Submitted
August 22, 2024
First Posted
October 22, 2024
Study Start
January 1, 2022
Primary Completion
November 30, 2024
Study Completion
November 30, 2024
Last Updated
October 22, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share