Development of Visual Function Evaluation Method (2)

Astellas Pharma Inc8 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Retinitis Pigmentosa

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Site JP00001

Kobe, Hyōgo, Japan

Outcomes

Primary Outcomes

Slit-lamp-microscopy

To assess the visual function.

Time frame: Up to 3 months

Optical Coherence Tomography (OCT) test

To assess the visual function.

Time frame: Day 1

Early Treatment Diabetic Retinopathy Study (ETDRS)

To assess the visual function.

Time frame: Up to 3 months

The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25)

NEI VFQ 25 is a questionnaire intended to measure visual function and quality of life. It has 25 questions. The original response of each item are coded as per the NEI VFQ scoring system ranging from 0 (worst) to 100 (best).

Time frame: Up to 3 months

The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11)

NEI VFQ 11 is a questionnaire intended to measure visual function and quality of life. It has 11 questions. The original response of each item are coded as per the NEI VFQ scoring system ranging from 0 (worst) to 100 (best).

Time frame: Up to 3 months

Nottingham Adjustment Scale Japanese Version (NAS-J)

NAS-J is the Japanese version of NAS which measures psychological adjustment to the visual impairment, and to assess its validity and reliability. The NAS is composed of 7 psychological subscales including anxiety-depression, self-esteem, attitude to disability, locus of control, acceptance of disability, self-efficacy and attributional style. The original response of each item are coded as per the NAS-J scoring system ranging from 0 (lowest psychological adjustment) to 100 (highest psychological adjustment).

Time frame: Up to 3 months

Daily living task dependent on vision (DLTV) questionnaire

Data from ClinicalTrials.gov

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