N/A
N=30
Transepithelial Corneal Cross-linking Using Iontophoresis
Progressive Keratoconus
Bottom Line
View on ClinicalTrials.gov: NCT02117999 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: K-max — -0.52; -0.82 Diopters (D) — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cross-linking with iontophoresis (Device); Standard corneal cross-linking (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fondazione G.B. Bietti, IRCCS
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY K-max |
-0.52; -0.82 | <0.05 sig |
| PRIMARY Corneal Endothelial Cell Density |
2675; 2658 | 0.05 |
| SECONDARY Optical Aberrations |
2.19; 2.21 | — |
| SECONDARY Visual Acuity |
0.03; 0.01 | — |
| SECONDARY Contrast Sensitivity |
1.62; 1.63 | — |
| SECONDARY Central Retinal Thickness |
275; 277 | — |
Summary
The purpose of the present Randomized Clinical Trial (RCT) is to compare the efficacy and safety of transepithelial corneal cross-linking using iontophoresis (T-ionto CL) to treat progressive keratoconus in comparison with standard cross-linking (standard CL).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of progressive keratoconus
Exclusion Criteria
- Anterior corneal curvature steeper than 61 D;
- central corneal thickness <400 um
- corneal scarring;
- descemetocele;
- history of herpetic keratitis;
- Concomitant eye diseases;
- Inflammatory eye diseases;
- Glaucoma;
- Cataract;
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT02117999). 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.