Skip to content

Exploration of visual function evaluation methods and clinical endpoints in patients with ultra-low vision

Exploration of visual function evaluation methods and clinical endpoints in patients with ultra-low vision - Exploration of visual function evaluation methods and clinical endpoints in patients with ultra-low vision

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000047757
Enrollment
65
Registered
2022-05-16
Start date
2022-06-01
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

Inherited Retinal Disease: IRD

Interventions

None listed

Sponsors

Keio University school of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: [Inclusion Criteria for IRD Subject] -Age: Men and women who are at least 20 years old at the time of obtaining consent. -Patients diagnosed with IRD (depending on phenotype). -At the time of obtaining consent, visual acuity of the worse eye is less than or equal to the counting finger (i.e. no light perception, light perception, hand motion, and counting finger) [Inclusion Criteria for Healthy Subject] -Age: Men and women who are at least 20 years old at the time of obtaining consent. -Those who have no severe refractive error (severe refractive error: spherical equivalent -6D and less or +5D and more) -Best-corrected visual acuity (decimal) 1.0 or better of both eyes at the time of obtaining consent.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
-Full-field retinal sensitivity to light by full-field stimulus threshold (FST) testing

Secondary

MeasureTime frame
-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

Countries

Japan

Contacts

Public ContactToshihide Kurihara

Keio University School of Medicine Department of Ophthalmology

kurihara@z8.keio.jp070-4921-5196

Outcome results

None listed

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