KeraVio study with cyanocobalamin

JRCT ID: jRCTs032230104

Registered date:01/06/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Keratoconus
• Date of first enrollment: 01/07/2023
• Target sample size: 3
• Study type: Interventional
• Intervention(s): Violet light emitting glass TLG-003

Outcome(s)

• Primary Outcome: Kmax

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Hidenaga Kobashi
• Secondary Sponsor: Tsubota Laboratory, Inc