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KeraVio study with cyanocobalamin

Efficacy and Safety of KeraVio treatment with Cyanocobalamin Ophthalmic Solution and Violet Light

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032230104
Enrollment
3
Registered
2023-06-01
Start date
2023-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus Keratoconus

Interventions

Sponsors

Hidenaga Kobashi
Lead Sponsor
Tsubota Laboratory, Inc
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Kmax

Secondary

MeasureTime frame
1. Corneal shape analyzer (minimum corneal thickness, demarcation line) 2. Corrected visual acuity 3. Naked eye vision 4. Perceived spherical power 5. Subjective astigmatism frequency 6. Intraocular pressure 7. Corneal endothelial cell density 8. Corneal opacity and scarring 9. Slit lamp microscope and fundus examination 10. Retinal optical coherence tomography OCT 11. Adverse Events, Reports from Subjects or Delegates

Contacts

Public ContactKondo Shinichiro

Tsubota Laboratory, Inc

kondo@tsubota-lab.com+81-3-6384-2866

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026