Actively Recruiting
Endothelial Side Up Inverted Femtosecond Laser Assisted DSAEK a Pilot Study
Led by Dar El Oyoun Hospital · Updated on 2024-10-22
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate clinical and anatomical outcomes of a corneal transplant technique called DSAEK, using grafts prepared with a Femto LDV laser from the endothelial side. The study focuses on patients with corneal conditions like Fuchs' endothelial dystrophy and pseudophakic bullous keratopathy, where the corneal endothelium is damaged. It explores how this method may improve vision and graft smoothness compared to traditional transplant surgeries. The procedure involves creating an ultrathin graft of about 100 micrometers in thickness and 7.5 mm diameter using the Femto LDV Z8 laser. The graft is inverted and placed with the endothelial side up inside the eye. It is coated with Viscoat to protect the cells, then inserted through a small corneal incision after the damaged Descemet's membrane is removed. An air bubble is used to press the graft into place for 10 minutes. Participants will be monitored for up to 6 months after surgery. Researchers will assess best-corrected visual acuity and endothelial cell count at 3 and 6 months. Additional measurements include central corneal thickness and donor endothelial thickness. The study also examines the anatomical smoothness of the graft interface to understand healing and graft quality. This pilot study is led by Dar El Oyoun Hospital and does not involve masking or placebo groups.
CONDITIONS
Brief Title
Endothelial Side Up Inverted Femtosecond Laser Assisted DSAEK
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with Fuchs' endothelial dystrophy
- Patients with bullous keratopathy caused by intraocular surgeries, iridocorneal endothelial syndrome, or viral keratitis
You will not qualify if you...
- Bullous keratopathy caused by glaucoma or eye trauma
- Corneal stromal scarring or opacities
- Diseases not affecting the corneal endothelium, such as corneal ectasia (keratoconus, keratoglobus, pellucid marginal degeneration)
- Epithelial, Bowman layer/anterior stromal, and stromal dystrophies
- Hypotonic eyes
- Retinal diseases
- Any type of optic atrophy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery and immediate post-operative period
Participants undergo the endothelial side up inverted femtosecond laser assisted DSAEK surgery to treat corneal endothelial dysfunction. After surgery, immediate post-operative care includes graft positioning and compression with an air bubble.
1 surgical visit (in-person)
Duration - 6 months
Participants are monitored after surgery to assess visual acuity, endothelial cell count, and corneal thickness at 3 and 6 months to evaluate clinical and anatomical outcomes.
Visits at 3 months and 6 months (in-person)
Trial Site Locations
Total: 1 location
1
Dar el Oyoun
Giza, Egypt
Actively Recruiting
Research Team
T
Tarek H Nasr, Msc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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