Validation of an Activities-of-daily-living Framework at Different Combinations of Light Temperature and Light Intensity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Supermarket Receipt (SupRe) score
研究概览
简要总结
Primary objective of this study is the construction and validation of an experimental environment for the simulation of a variety of near- and intermediate-vision activities of daily living (ADLs) in different combinations of light temperature and light intensity.
详细描述
Among the objectives of the study is to validate a framework of ADLs that require near and intermediate vision and better reflect visual capacity, in a special experimental environment of 9 different combinations of light temperature and light intensity.
The final list consists of the following ten basic ADL tasks:
- Phone Book Search (PBS), 2. Supermarket receipt (SupRe), 3. Book reading (BR), 4. Cellular message (CM), 5. Cellular entry search (CES), 6. Reading computer screen (RCS), 7. Drops bottle reading (DR), 8. Subtitles reading (SubRe), 9. Open door test (ODT), and, 10. Screwdriver test (ST).
The 9 light combinations are the following:
3000 K - 25 fc, 3000 K - 50 fc, 3000 K - 75 fc 4000 K - 25 fc, 4000 K - 50 fc, 4000 K - 75 fc 6000 K - 25 fc, 6000 K - 50 fc, 6000 K - 75 fc
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •normophakic participants with a clear natural lens
- •age between 40 to 75 years old
- •UNVA: logMAR 0.1, 0.4, or 0.7
排除标准
- •astigmatism >1.00 diopters
- •intraocular pressure lowering medications
- •former incisional eye surgery
- •corneal or fundus disease
- •diabetes mellitus
- •autoimmune diseases
- •neurological, psychiatric or mental diseases
结局指标
主要结局
Supermarket Receipt (SupRe) score
时间窗: through study completion, an average of 6 months
Patient is required to find and read three products from a typical supermarket receipt in the nine different combinations of light temperature and light intensity. Different products are asked to be found in each combination. \[scale's best value: 100, scale's worst value: 0\]
Open Door Test (ODT) score
时间窗: through study completion, an average of 6 months
Patient is required to find a specific key from a keychain that holds 10 keys and put it in the corresponding door keyhole in the nine different combinations of light temperature and light intensity. Different keychains are given in each combination. \[scale's best value: 100, scale's worst value: 0\]
Screwdriver Test (ST) score
时间窗: through study completion, an average of 6 months
Patient is required to select one among three screwdrivers and insert it in the appropriate screw among a variety of screw types in the nine different combinations of light temperature and light intensity. Different screwdrivers are given to be selected in each combination. \[scale's best value: 100, scale's worst value: 0\]
Book Reading (BR) score
时间窗: through study completion, an average of 6 months
Patient is required to read an excerpt of a predetermined length in a novel in the nine different combinations of light temperature and light intensity. A different excerpt of the same length is asked to be read in each combination. \[scale's best value: 100, scale's worst value: 0\]
Cellular Entry Search (CES) score
时间窗: through study completion, an average of 6 months
Patient is required to find and read one specific entry on a cellular phone in the nine different combinations of light temperature and light intensity. Different entries are asked to be found in each combination. \[scale's best value: 100, scale's worst value: 0\]
Phone Book Search (PBS) score
时间窗: through study completion, an average of 6 months
Patient is required to find and read a specific entry in a regular phonebook catalog in the nine different combinations of light temperature and light intensity. A different entry is asked to be found in each combination. \[scale's best value: 100, scale's worst value: 0\]
Subtitles Reading (SubRe) score
时间窗: through study completion, an average of 6 months
Patient is required to correctly read movie subtitles from a one-minute movie excerpt on a computer screen in the nine different combinations of light temperature and light intensity. Different movie excerpts are shown in each combination. \[scale's best value: 100, scale's worst value: 0\]
Cellular message (CM) score
时间窗: through study completion, an average of 6 months
Patient is required to read a Short Message Service (SMS) on a cellular phone in the nine different combinations of light temperature and light intensity. A different SMS is asked to be read in each combination. \[scale's best value: 100, scale's worst value: 0\]
Reading Computer Screen (RCS) score
时间窗: through study completion, an average of 6 months
Patient is required to correctly read text of a predetermined length from a computer screen in the nine different combinations of light temperature and light intensity. Different texts of the same length are asked to be read in each combination. \[scale's best value: 100, scale's worst value: 0\]
Drops bottle Reading (DR) score
时间窗: through study completion, an average of 6 months
Patient is required to correctly read the expiration date printed on three typical eye dropper bottles in the nine different combinations of light temperature and light intensity. Different eye dropper bottles are given to be read in each combination. \[scale's best value: 100, scale's worst value: 0\]
次要结局
- Uncorrected Intermediate Visual Acuity (UIVA)(through study completion, an average of 6 months)
- 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) score(through study completion, an average of 6 months)
- Uncorrected Distance Visual Acuity (UDVA)(through study completion, an average of 6 months)
- Uncorrected Near Visual Acuity (UNVA)(through study completion, an average of 6 months)
研究者
Georgios Labiris
Professor (Associate) of Democritus University of Thrace
Democritus University of Thrace