UMIN ID: UMIN000047757
Registered date:16/05/2022
Exploration of visual function evaluation methods and clinical endpoints in patients with ultra-low vision
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Inherited Retinal Disease: IRD |
| Date of first enrollment | 2022/06/01 |
| Target sample size | 65 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | -Full-field retinal sensitivity to light by full-field stimulus threshold (FST) testing |
|---|---|
| Secondary Outcome | -Slit-lamp microscopy -Visual acuity test -Visual field test -Fundus photography -Fundus autofluorescence -OCT -ERG -Visual evoked potential -Electrically evoked response -Mobility test -ADL test -Questionnaire regarding QOL |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Healthy people with other eye complications that significantly affect visual field or visual acuity, and with abnormal findings detected by slit-lamp microscopy, fundoscopy, OCT. 2. Those who underwent eye surgery within 3 months. 3. Subjects who have with a history of allergy to the agents to be used in this study, e.g. mydriatic agent, anesthetic agent, etc. 4. Subjects who are diagnosed with dementia or mental illness. 5. Those who are pregnant or lactating. 6. Those who are currently participating in other clinical trials. 7. Those who have participated in a clinical trial for therapeutic purposes within the past 3 months. 8. Those who with a history or suspected or confirmed diagnosis of alcohol or other drug addictions. 9. Those who unable to understand the evaluation and examination procedures. 10. Those who, in the judgment of the principal investigator, are considered to be at risk of becoming ineligible for the study. 11. Those who are judged by the principal investigator or other investigators to be inappropriate for participation in this study. |
Related Information
| Primary Sponsor | Keio University school of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Restore Vision Inc. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Toshihide Kurihara |
| Address | 35 Shinanomachi Shinjyuku-ku Tokyo, Japan Japan 160-8582 |
| Telephone | 070-4921-5196 |
| kurihara@z8.keio.jp | |
| Affiliation | Keio University School of Medicine Department of Ophthalmology |
| scientific contact | |
| Name | Kazuno Negishi |
| Address | 35 Shinanomachi Shinjyuku-ku Tokyo, Japan Japan |
| Telephone | 03-5843-6993 |
| kazunonegishi@keio.jp | |
| Affiliation | Keio University School of Medicine Department of Ophthalmology |