Amount of Corneal Flattening (Kmax Flattening), Change in the Endothelial Cell Count
Conditions
Brief summary
The objective of this study is to compare the clinical effectiveness and safety of Topo-Pachymetric Customized Accelerated Epithelium-On (aCFXL) to Standard Accelerated Epithelium-Off (aCXL) Corneal Collagen Cross-Linking in the management of keratoconus. The study aims to evaluate visual and structural outcomes, to provide valuable insights into optimizing treatment strategies.
Interventions
PROCEDURECorneal cross linking
Applying UVA irradiation to the cornea after soaking with riboflavin
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age: 18 years or older 2. Corrected distance visual acuity (CDVA) of ≥ 0.3 Snellen. 3. Central corneal thickness (de-epithelialized) of ≥ 400 micron. 4. Corneal endothelial count of ≥ 2000.
Exclusion criteria
1. Previous eye surgery 2. The presence of lesions other than keratoconus, central or paracentral scaring 3. History of Cross linking 4. History of viral keratitis 5. Connective tissue diseases 6. Pregnancy or lactation during the study. 7. The presence of nystagmus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of corneal flattening | 6 months | Kmax flattening |
| Change in the endothelial cell count. | 6 months | the stability or decrease in the endothelial cell count. |
Secondary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity | 6 months |
Countries
Egypt
Outcome results
None listed