Development of Visual Function Evaluation Method (2)

Study Overview
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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.

Official Title
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Calibration of Visual Function Evaluation Tests in Patients With Severe Vision Loss

Conditions
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Retinitis Pigmentosa

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retinitis pigmentosa<br>Retinitis pigmentosa patients with severe visual impairment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit-lamp-microscopy | To assess the visual function. | Up to 3 months | 
| Optical Coherence Tomography (OCT) test | To assess the visual function. | Day 1 | 
| Early Treatment Diabetic Retinopathy Study (ETDRS) | To assess the visual function. | 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). | 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). | 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). | Up to 3 months | 
| Daily living task dependent on vision (DLTV) questionnaire | DLTV is a quality of life questionnaire composed of 22 items to obtain estimates of self-reported ability to perform vision-related tasks in persons with visual impairment. Participants rate items on a four-point scale, with Can't see to do (score, 1), A lot of difficulty (score, 2), A little difficulty (score, 3), andNo difficulty (score, 4). The original response of each item are coded as per the DLTV scoring system ranging from 0 (worst) to 100 (best). | Up to 3 months | 
| Table test | To assess the visual function. | Up to 3 months | 
| Monitor test | To assess the visual function. | Up to 3 months | 
| Pupillary function test | To assess the visual function. | Up to 3 months | 
| Full field stimulus threshold testing (FST) | To assess the visual function. | Up to 3 months | 
| White flash visual evoked potential (VEP) test | To assess the visual function. | Up to 3 months | 
| Color flash VEP test | To assess the visual function. | Up to 3 months | 
| Electrically evoked response (EER) test | To assess the visual function. | Up to 3 months | 
| White flash Electroretinography (ERG) test | To assess the visual function. | Day 1 | 
| Multifocal ERG test | To assess the visual function. | Up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinitis pigmentosa, Visual function evaluation