Inverted Femtosecond Laser Assisted DSAEK for Corneal Transplantation
Endothelial Side Up Inverted Femtosecond Laser Assisted DSAEK a Pilot Study
This study is testing a new laser technique for corneal transplants to see if it helps people with eye conditions like Fuchs' dystrophy and bullous keratopathy recover better and see more clearly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Sex | All |
| Sponsor | Dar El Oyoun Hospital Academic / other |
| Locations | 1 site (Giza) |
| Trial ID | NCT06652321 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the outcomes of a novel corneal transplantation technique known as Endothelial Side Up Inverted Femtosecond Laser Assisted DSAEK. The study focuses on patients with conditions like Fuchs' endothelial dystrophy and pseudophakic bullous keratopathy, assessing postoperative visual acuity and endothelial cell counts, as well as the smoothness of the graft interface. By utilizing femtosecond laser technology, the trial aims to improve the precision and effectiveness of the DSAEK procedure, which is less invasive than traditional corneal transplants. The goal is to enhance recovery times and reduce complications associated with corneal grafts.
Who should consider this trial
Good fit: Ideal candidates for this study include individuals with Fuchs' endothelial dystrophy or bullous keratopathy resulting from intraocular surgeries.
Not a fit: Patients with bullous keratopathy due to glaucoma or ocular trauma, or those with significant corneal scarring, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved visual outcomes and reduced complications for patients undergoing corneal transplantation.
How similar studies have performed: While the approach is innovative, similar studies have shown promise in improving corneal transplant techniques, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients with Fuchs' endothelial dystrophy Patients with bullous keratopathy secondary to intraocular surgeries, iridocorneal endothelial syndrome, or viral keratitis Exclusion Criteria: 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
Where this trial is running
Giza
- Dar el Oyoun — Giza, Egypt (Recruiting)
Study contacts
- Study coordinator: Tarek H Nasr, Msc
- Email: tarekhaytham@gmail.com
- Phone: +201002412992
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.