N/A
N=21
Early Experience With Descemet's Stripping Automated Endothelial Keratoplasty
Corneal Edema Secondary to Corneal Endothelial Dystrophy
Bottom Line
View on ClinicalTrials.gov: NCT00744796 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Best Spectacle Corrected Visual Acuity (BSCVA) — 1; 3; 7; 9 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- DSAEK (Procedure); Anterior Segment Optical Coherence Topography (OCT) (Diagnostic_test); Best Spectacle Corrected Visual Acuity (BSCVA) (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Spectacle Corrected Visual Acuity (BSCVA) |
1; 3; 7; 9; 1 | — |
| PRIMARY Central Corneal Thickness |
686.6 | — |
| PRIMARY Peripheral Corneal Thickness |
710 | — |
Summary
The purpose of this study is to report the early clinical outcomes in patients undergoing Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) for corneal edema secondary to corneal endothelial cell dysfunction, and to correlate this clinical data with the latest generation of imaging modalities available for the anterior segment.
Eligibility Criteria
Inclusion Criteria
- Patients aged 18 and up, where any age over 89 will be recorded as 'greater than 89', who have reviewed and understood the study consent form will be invited to participate in this study.
- They will be recruited based on diagnosis of corneal edema secondary to endothelial cell dysfunction undergoing DSAEK either alone or in conjunction with phacoemulsification and intraocular lens implantation at the University of Texas Southwestern Medical Center at Dallas.
Exclusion Criteria
- Patients younger than 18 years will not be considered for this trial.
- The study will include all patients (no exclusion criteria) who have undergone and will undergo DSAEK implantation for corneal edema secondary to corneal endothelial dystrophy with an effort to determine its success.
Data sourced from ClinicalTrials.gov (NCT00744796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.