Development of Visual Function Evaluation Method (2)
- Conditions
- Retinitis Pigmentosa
- Registration Number
- NCT03626207
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent and at screening
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Slit-lamp-microscopy Up to 3 months To assess the visual function.
Pupillary function test Up to 3 months To assess the visual function.
Color flash VEP test Up to 3 months To assess the visual function.
White flash Electroretinography (ERG) test Day 1 To assess the visual function.
Multifocal ERG test Up to 3 months To assess the visual function.
Optical Coherence Tomography (OCT) test Day 1 To assess the visual function.
Full field stimulus threshold testing (FST) Up to 3 months To assess the visual function.
Early Treatment Diabetic Retinopathy Study (ETDRS) Up to 3 months To assess the visual function.
The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) Up to 3 months 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).
Nottingham Adjustment Scale Japanese Version (NAS-J) Up to 3 months 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).
Daily living task dependent on vision (DLTV) questionnaire Up to 3 months 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).
White flash visual evoked potential (VEP) test Up to 3 months To assess the visual function.
The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11) Up to 3 months 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).
Electrically evoked response (EER) test Up to 3 months To assess the visual function.
Table test Up to 3 months To assess the visual function.
Monitor test Up to 3 months To assess the visual function.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Site JP00001
🇯🇵Kobe, Hyogo, Japan