Status:
COMPLETED
Development of Visual Function Evaluation Method
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Retinitis Pigmentosa
Eligibility:
All Genders
20+ years
Brief Summary
The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient
Detailed Description
This study is a prospective observational study which consists of 4 Parts; Part 1A, 1B, 2 and 3. Part 1A has been conducted on 6 subjects diagnosed with retinitis pigmentosa. Additional examination wi...
Eligibility Criteria
Inclusion
- Inclusion Criteria for patients with retinitis pigmentosa:
- Age: ≥ 20 years
- Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent
- Inclusion Criteria for healthy Volunteers:
- Age: ≥ 35 and ≤ 75 years
- Subjects with corrected visual acuity ≥ 1.0 with both eyes and without severe refractive error nor abnormal findings in slit-lamp microscopy, OCT, fundoscopy and pupillary function test at screening
- Exclusion Criteria:
- Subjects who have participated in any other clinical trial or clinical study involving visual function evaluation within 6 months
- Subjects who have history of surgery, past history, and complications (cardiac/ hepatic/ renal/ respiratory/ hematological diseases, optic nerve diseases causing marked loss of visual field, and uveitis etc.) that potentially affect evaluation and safety of the study
- Pregnant women
- Subjects who are judged that continuation of the study is difficult during the study period
- Subjects who are employed by the company sponsoring this study, an organization or institution related to this study
Exclusion
Key Trial Info
Start Date :
November 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 21 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03281005
Start Date
November 1 2017
End Date
November 21 2019
Last Update
October 21 2024
Active Locations (1)
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1
Site JP00001
Meguro-ku, Tokyo, Japan