Development of Visual Function Evaluation Method

NCT ID: NCT03281005

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2019-11-21

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 will be performed using alternative devices imported outside Japan on subjects who completed Part 1A and re-consented (Part 1B). Based on the interim result of Part 1A, Part 2 will be conducted on another 6 subjects with retinitis pigmentosa with improved methodology and the devices used in Part 1B. Part 3 will be conducted in 6 healthy volunteers to obtain comparative data using devices used in Part 1B.

Conditions

Retinitis Pigmentosa

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Retinitis pigmentosa in Part 1A

Retinitis pigmentosa patients with severe visual impairment

No interventions assigned to this group

Retinitis pigmentosa in Part 1B

Retinitis pigmentosa patients with severe visual impairment

No interventions assigned to this group

Retinitis pigmentosa in Part 2

Retinitis pigmentosa patients with severe visual impairment

No interventions assigned to this group

Healthy volunteers in Part 3

Healthy volunteers

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age: ≥ 20 years
• Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent

• 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Site JP00001

Meguro-ku, Tokyo, Japan

Countries

Japan

References

Fujinami-Yokokawa Y, Yang L, Joo K, Tsunoda K, Liu X, Kondo M, Ahn SJ, Li H, Park KH, Tachimori H, Miyata H, Woo SJ, Sui R, Fujinami K. Occult Macular Dysfunction Syndrome: Identification of Multiple Pathologies in a Clinical Spectrum of Macular Dysfunction with Normal Fundus in East Asian Patients: EAOMD Report No. 5. Genes (Basel). 2023 Sep 26;14(10):1869. doi: 10.3390/genes14101869.

Reference Type: DERIVED

PMID: 37895218 (View on PubMed)

Other Identifiers

CRE170041

Identifier Type: -

Identifier Source: org_study_id