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The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retinitis pigmentosa | Retinitis pigmentosa patients with severe visual impairment |
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| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Retinitis pigmentosa
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site JP00001 | Kobe | Hyōgo | Japan |
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
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| 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), and"No 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 |
| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |