Validation of an Activities-of-daily-living Framework at Different Light Conditions
NCT ID: NCT05005624
Last Updated: 2022-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2020-07-01
2021-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Validation group 1 (VG-1)
20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.1 logMAR (Snellen 20/25)
ADL performance
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
Validation group 2 (VG-2)
20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.4 logMAR (Snellen 20/50)
ADL performance
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
Validation group 3 (VG-3)
20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.7 logMAR (Snellen 20/100)
ADL performance
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
Interventions
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ADL performance
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
Eligibility Criteria
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Inclusion Criteria
* age between 40 to 75 years old
* UNVA: logMAR 0.1, 0.4, or 0.7
Exclusion Criteria
* glaucoma
* intraocular pressure lowering medications
* former incisional eye surgery
* corneal or fundus disease
* diabetes mellitus
* autoimmune diseases
* neurological, psychiatric or mental diseases
40 Years
75 Years
ALL
Yes
Sponsors
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Democritus University of Thrace
OTHER
Responsible Party
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Georgios Labiris
Professor (Associate) of Democritus University of Thrace
Principal Investigators
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Georgios Labiris, MD, PhD
Role: STUDY_CHAIR
Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
Locations
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Department of Ophthalmology, University Hospital of Alexandroupolis
Alexandroupoli, Evros, Greece
Countries
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Other Identifiers
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DUTH/EHDE9/29-5-2020
Identifier Type: -
Identifier Source: org_study_id
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