KeraVio study with cyanocobalami

Phase 3

• Conditions: Keratoconus; H186

• Registration Number: JPRN-jRCTs032230104
• Lead Sponsor: Hidenaga Kobashi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

The principal investigator diagnosed keratoconus and satisfy one or more of the following items 1~5 within the 6 months immediately preceding the start of this study.
1.Corneal shape analysis Kmax increased by more than 0.5 D
2.Corneal shape analysis Posterior corneal best sphere fit (BSF) increased by more than 0.2 mm
3.Subjective astigmatism frequency increased by 0.5 D or more
4.Increased refractive index by 0.5 D or more (myopia)
5.Minimum corneal thickness reduced by more than 5 micrometre

Exclusion Criteria

Subjects who meet one or more of the following criteria will be excluded from the study:
1. Taking psoralen
2. History or suspicion of photosensitivity
3. History of epilepsy
4. History of allergy to fluorescein
5. When corneal transplantation may be required during the clinical research period
6 In addition, when the principal investigator deems the patient to be inappropriate as a subject of this research.

Study & Design

• Study Type: Interventional
• Study Design: Not specified