KeraVio study (KeraVio study)

Phase 3

• Conditions: Keratoconus; H186

• Registration Number: JPRN-jRCTs032190267
• Lead Sponsor: Itoi Motozumi

Brief Summary

KeraVio with VL only demonstrated no efficacy in terms of the halt of keratoconus progression.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-26
• Study Completion: 2022-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Eyes with progressive keratoconus over the preceding 6 months as the following criteria.
1. an increase of at least 0.5 D in the Kmax
2. an increase of at least 0.2 mm in the corneal best sphere fit (BSF)
3. an increase of at least 0.5 D in the manifest cylindrical refraction
4. an increase of at least 0.5 D in the manifest refractive spherical equivalent
5. an decrease of at least 5 micro m in the thinnest corneal thickness

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified