KeraVio study

Phase 2

• Conditions: Keratoconus, Pellucid Marginal Corneal Degeneration, Iatrogenic Keratectasia; H186

• Registration Number: JPRN-jRCTs032180217
• Lead Sponsor: KOBASHI HIDENAGA

Brief Summary

Based on our 6-month results, daily treatment of progressive corneal ectasia with KeraVio can halt disease progression without any safety concerns.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-08
• Study Completion: 2019-10-31
• Results First Posted: 2020-09-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. We defined the progression of corneal ectasia over the preceding 12 months as the following criteria.
- an increase of at least 1.00 diopter (D) in the steepest keratometry
- an increase of at least 1.00 D in the manifest cylindrical refraction
- an increase of at least 1.00 D in the manifest refractive spherical equivalent
- an decrease of at least 0.1 mm in base curve of hard contact lens
2. Possible to visit clinic based on the protocol
3. Agreement with this trial assignment from patients or parental authority
4. 15 years old or more in patients' age

Exclusion Criteria

1. Thinnest corneal thickness < 300 micron
2. Present medication of Psoralen
3. History of photodermatosis
4. History of epilepsy
5. History of fluorescein induced allergy
6. Cases with possibly undergoing keratoplasty during the observation period
7. Cases considered as inappropriate by physicians

Study & Design

• Study Type: Interventional
• Study Design: Not specified