Development of Visual Function Evaluation Method (2)

NCT ID: NCT03626207

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-04

Study Completion Date

2019-06-26

Brief Summary

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The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient.

Detailed Description

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Conditions

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Retinitis Pigmentosa

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Retinitis pigmentosa

Retinitis pigmentosa patients with severe visual impairment

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent and at screening

Exclusion Criteria

* Subjects should not have participated in any other clinical trial or clinical study involving visual function evaluation within 6 months
* 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

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Site JP00001

Kobe, Hyōgo, Japan

Site Status

Countries

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Japan

Other Identifiers

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CLR180001

Identifier Type: -

Identifier Source: org_study_id

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