Calibration of Visual Function Evaluation Tests in Patients With Severe Vision Loss
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Retinitis Pigmentosa
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Color flash VEP test in Part 1A and 2
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient
Detailed Description
This study is a prospective observational study which consists of 4 Parts; Part 1A, 1B, 2 and 3. Part 1A has been conducted on 6 subjects diagnosed with retinitis pigmentosa. Additional examination will be performed using alternative devices imported outside Japan on subjects who completed Part 1A and re-consented (Part 1B). Based on the interim result of Part 1A, Part 2 will be conducted on another 6 subjects with retinitis pigmentosa with improved methodology and the devices used in Part 1B. Part 3 will be conducted in 6 healthy volunteers to obtain comparative data using devices used in Part 1B.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Subjects who have participated in any other clinical trial or clinical study involving visual function evaluation within 6 months
- •Subjects who have 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
Outcomes
Primary Outcomes
Color flash VEP test in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function
Color flash VEP test in Part 1B and 3
Time Frame: Day 1
To assess the visual function
White flash VEP test in Part 1B and 3
Time Frame: Day 1
To assess the visual function
Electrically evoked response (EER) test in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function
EER test in Part 1B and 3
Time Frame: Day 1
To assess the visual function
White flash electroretinography test in Part 1A, 1B, 2 and 3
Time Frame: Day 1
To assess the visual function
Pupillary function test in Part 2
Time Frame: Up to week 8
To assess the visual function
Pupillary function test in Part 1B and 3
Time Frame: Day 1
To assess the visual function
Full field stimulus threshold testing (FST) in Part 2
Time Frame: Up to week 8
To assess the visual function
FST in Part 1B
Time Frame: Day 1
To assess the visual function
Slit-lamp microscopy in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function
Slit-lamp microscopy in Part 1B and 3
Time Frame: Day 1
To assess the visual function
Optical Coherence Tomography (OCT) test in Part 1A and 2
Time Frame: Day 1
To assess the visual function
Visual acuity test with Early Treatment Diabetic Retinopathy Study (ETDRS) in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function
Visual acuity test with ETDRS in Part 1B
Time Frame: Day 1
To assess the visual function
The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function and the quality of life (QOL)
The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11) in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function and QOL
Nottingham Adjustment Scale Japanese Version (NAS-J) in Part 1A and 2
Time Frame: Up to week 8
To assess the psychological adjustment
Daily living task dependent on vision (DLTV) in Part 1A and 2
Time Frame: Up to week 8
To assess QOL
Table test in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function
Metropsis test in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function
Low vision evaluator (LoVE) in Part 1A
Time Frame: Up to week 8
To assess the visual function
White flash visual evoked potential (VEP) test in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function