UMIN ID: UMIN000002947
Registered date:28/12/2009
Evaluation of efficacy and safety of riboflavin/UVA treatment for keratoconus/keratectasia
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Keratoconus, keratectasia |
| Date of first enrollment | 2009/02/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Collagen fibers of the corneal stroma will be crosslinked by the combination of instillation of riboflavin solution and ultraviolet-A irradiation for 30 minutes after corneal epithelial debridement. |
Outcome(s)
| Primary Outcome | Visual acuity, refraction, corneal curvature, corneal topography, corneal endothelial cell counts, and incidence of complications |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 14years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. The corneal thickness less than 400 micrometer 2. Those who implanted medical instruments, such as pacemaker. 3. Ocular diseases, such as infection, corneal scar, herpetic keratitis, and/or nystagmus 4. Systemic diseases affecting corneal would healing 5. Eyes with narrow angle. Pregnant or breast-feeding women. 6. Occupation, by which refractive surgery is not arrowed |
Related Information
| Primary Sponsor | Department of Ophthalmology, Keio University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Naoko Kato |
| Address | Shinanomachi 35, Shinjuku-ku, Tokyo Japan |
| Telephone | 03-3353-1211 |
| nkato@ndmc.ac.jp | |
| Affiliation | Keio University School of Medicine Department of Ophthalmology, Refractive Surgery Clinic |
| scientific contact | |
| Name | Kazuo Tsubota |
| Address | Shinanomachi 35, Shinjuku-ku, Tokyo Japan |
| Telephone | 03-3353-1211 |
| keio.eye.research.sec@gmail.com | |
| Affiliation | Keio University School of Medicine Department of Ophthalmology |