Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia
Keratoconus · Post-Refractive Ectasia
Bottom Line
View on ClinicalTrials.gov: NCT01143389 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Riboflavin (Drug); UVX light (Device)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Price Vision Group
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Maximum Keratometry From Baseline to 6 Months After Treatment |
0.76; 0.97 | — |
| SECONDARY Pachymetry |
438; 434 | — |
| SECONDARY Corrected Distance Visual Acuity (CDVA) |
0.32; 0.31 | — |
| SECONDARY Uncorrected Distance Visual Acuity (UDVA) |
0.95; 0.91 | — |
Summary
Eligibility Criteria
Inclusion Criteria
- 10 years of age or older
- Having documented ectasia on topography or tomography after previous refractive surgery OR progressive keratoconus defined as one or more of the following changes over a period of 36 months or less before randomization:
- An increase of ≥ 1.00 D in the steepest keratometry value (or sim K)
- An increase of ≥ 1.00 D in regular astigmatism evaluated by subjective manifest refraction
- A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction
- Documented decrease in visual acuity associated with irregular astigmatism and topographic features of ectasia.
- Subjects with keratoconus diagnosis only:
a. Axial topography consistent with keratoconus b. Presence of central or inferior steepening on the Pentacam map. c. Presence of one or more slit lamp findings associated with keratoconus, such as: i. Fleischer ring ii. Vogt striae iii. Corneal thinning iv. Corneal scarring
- Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction:
Contact Lens Type Minimum Discontinuation Time Soft 3 Days Soft Extended Wear 1 Week Soft Toric 2 Weeks Rigid gas permeable 2 Weeks
- Signed written informed consent
Exclusion Criteria
- 1. Any keratoconus patient over 21 years of age without evidence of progression of his corneal deformity.
- Patients with excessively thin corneas. 3. Previous ocular condition in the eyes to be treated that may predispose the eye for future complications, for example:
a. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) b. Clinically significant corneal scarring in the proposed treatment zone 4. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
- A known sensitivity to treatment medications. 6. Patients with a current condition that, in the treating physician's opinion, would interfere with or prolong epithelial healing.
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
Data sourced from ClinicalTrials.gov (NCT01143389). 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.