Validation of an Activities-of-daily-living Framework at Different Light Conditions

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 1. 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

Official Title
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Validation of an Activities-of-daily-living Framework at Different Combinations of Light Temperature and Light Intensity

Conditions
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Presbyopia, Near Vision, Reading, Daily Activities

Intervention / Treatment
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* Other: ADL performance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: normophakic participants with a clear natural lens age between 40 to 75 years old UNVA: logMAR 0.1, 0.4, or 0.7 Exclusion Criteria: astigmatism >1.00 diopters glaucoma intraocular pressure lowering medications former incisional eye surgery corneal or fundus disease diabetes mellitus autoimmune diseases neurological, psychiatric or mental diseases

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Validation group 1 (VG-1)<br>20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.1 logMAR (Snellen 20/25) | Other: ADL performance<br>* All validation groups address the following ten ADL tasks in 9 different combinations of light temperature (in Kelvins - K) and light intensity (in foot candles - fc) in order possible differences to be revealed among the validation groups and light combinations: 1. 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<br>|
| Validation group 2 (VG-2)<br>20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.4 logMAR (Snellen 20/50) | Other: ADL performance<br>* All validation groups address the following ten ADL tasks in 9 different combinations of light temperature (in Kelvins - K) and light intensity (in foot candles - fc) in order possible differences to be revealed among the validation groups and light combinations: 1. 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<br>|
| Validation group 3 (VG-3)<br>20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.7 logMAR (Snellen 20/100) | Other: ADL performance<br>* All validation groups address the following ten ADL tasks in 9 different combinations of light temperature (in Kelvins - K) and light intensity (in foot candles - fc) in order possible differences to be revealed among the validation groups and light combinations: 1. 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phone Book Search (PBS) score | 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] | through study completion, an average of 6 months | 
| Supermarket Receipt (SupRe) score | 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] | through study completion, an average of 6 months | 
| Book Reading (BR) score | 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] | through study completion, an average of 6 months | 
| Cellular message (CM) score | 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] | through study completion, an average of 6 months | 
| Cellular Entry Search (CES) score | 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] | through study completion, an average of 6 months | 
| Reading Computer Screen (RCS) score | 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] | through study completion, an average of 6 months | 
| Drops bottle Reading (DR) score | 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] | through study completion, an average of 6 months | 
| Subtitles Reading (SubRe) score | 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] | through study completion, an average of 6 months | 
| Open Door Test (ODT) score | 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] | through study completion, an average of 6 months | 
| Screwdriver Test (ST) score | 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] | through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Distance Visual Acuity (UDVA) | Monocular and binocular UDVA of all groups is estimated using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance | through study completion, an average of 6 months | 
| Uncorrected Intermediate Visual Acuity (UIVA) | Monocular and binocular UIVA of all groups is estimated using web-based Democritus Digital Acuity Reading Test (wDDART) | through study completion, an average of 6 months | 
| Uncorrected Near Visual Acuity (UNVA) | Monocular and binocular UNVA of all groups is estimated using web-based Democritus Digital Acuity Reading Test (wDDART) | through study completion, an average of 6 months | 
| 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) score | Vision-specific quality of life of all participants is evaluated with the Greek version of NEI VFQ-25, which is handed to the patients prior to their ADL assessment. | through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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activities of daily living, presbyopia, light temperature, light intensity