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KeraVio study (KeraVio study)

Efficacy and Safety of minimally invasive corneal cross linking for patients with progressive keratoconus (KeraVio study)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032190267
Enrollment
20
Registered
2020-03-26
Start date
2020-05-25
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

Itoi Motozumi
Lead Sponsor
Tsubota Laboratory, Inc.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Kmax

Secondary

MeasureTime frame
1.Corneal Tomography (Thinnest corneal thickness, anterior and posterior parameters) 2.Best corrected visual acuity 3.Uncorrected visual acuity 4.Manifest refractive spherical equivalent 5.Manifest cylinder refraction 6.Intraocular pressure 7.Corneal endothelial cell density 8.Corneal haze, demarcation line 9.Slit lump examination 10.Optical coherence tomography 11.Dermal disorder 12.Adverse events and patient's report

Contacts

Public ContactHidenaga Kobashi

Tsubota Laboratory, Inc.

kobashi@v.tsubota-lab.com+81-3-6384-2866

Outcome results

None listed

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