Calibration of Visual Function Evaluation Tests in Patients With Severe Vision Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Color flash VEP test in Part 1A and 2
研究概览
简要总结
The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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
结局指标
主要结局
Color flash VEP test in Part 1A and 2
时间窗: Up to week 8
To assess the visual function
Color flash VEP test in Part 1B and 3
时间窗: Day 1
To assess the visual function
White flash VEP test in Part 1B and 3
时间窗: Day 1
To assess the visual function
Electrically evoked response (EER) test in Part 1A and 2
时间窗: Up to week 8
To assess the visual function
EER test in Part 1B and 3
时间窗: Day 1
To assess the visual function
White flash electroretinography test in Part 1A, 1B, 2 and 3
时间窗: Day 1
To assess the visual function
Pupillary function test in Part 2
时间窗: Up to week 8
To assess the visual function
Pupillary function test in Part 1B and 3
时间窗: Day 1
To assess the visual function
Full field stimulus threshold testing (FST) in Part 2
时间窗: Up to week 8
To assess the visual function
FST in Part 1B
时间窗: Day 1
To assess the visual function
Slit-lamp microscopy in Part 1A and 2
时间窗: Up to week 8
To assess the visual function
Slit-lamp microscopy in Part 1B and 3
时间窗: Day 1
To assess the visual function
Optical Coherence Tomography (OCT) test in Part 1A and 2
时间窗: Day 1
To assess the visual function
Visual acuity test with Early Treatment Diabetic Retinopathy Study (ETDRS) in Part 1A and 2
时间窗: Up to week 8
To assess the visual function
Visual acuity test with ETDRS in Part 1B
时间窗: Day 1
To assess the visual function
The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in Part 1A and 2
时间窗: 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
时间窗: Up to week 8
To assess the visual function and QOL
Nottingham Adjustment Scale Japanese Version (NAS-J) in Part 1A and 2
时间窗: Up to week 8
To assess the psychological adjustment
Daily living task dependent on vision (DLTV) in Part 1A and 2
时间窗: Up to week 8
To assess QOL
Table test in Part 1A and 2
时间窗: Up to week 8
To assess the visual function
Metropsis test in Part 1A and 2
时间窗: Up to week 8
To assess the visual function
Low vision evaluator (LoVE) in Part 1A
时间窗: Up to week 8
To assess the visual function
White flash visual evoked potential (VEP) test in Part 1A and 2
时间窗: Up to week 8
To assess the visual function
次要结局
未报告次要终点