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
- 8
- 试验地点
- 1
- 主要终点
- Table test
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent and at screening
排除标准
- •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
结局指标
主要结局
Table test
时间窗: Up to 3 months
To assess the visual function.
Monitor test
时间窗: Up to 3 months
To assess the visual function.
Slit-lamp-microscopy
时间窗: Up to 3 months
To assess the visual function.
Pupillary function test
时间窗: Up to 3 months
To assess the visual function.
Color flash VEP test
时间窗: Up to 3 months
To assess the visual function.
White flash Electroretinography (ERG) test
时间窗: Day 1
To assess the visual function.
Multifocal ERG test
时间窗: Up to 3 months
To assess the visual function.
Optical Coherence Tomography (OCT) test
时间窗: Day 1
To assess the visual function.
Full field stimulus threshold testing (FST)
时间窗: Up to 3 months
To assess the visual function.
Early Treatment Diabetic Retinopathy Study (ETDRS)
时间窗: Up to 3 months
To assess the visual function.
The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: Up to 3 months
To assess the visual function.
The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11)
时间窗: 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
时间窗: Up to 3 months
To assess the visual function.
次要结局
未报告次要终点