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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05005624
Enrollment
60
Registered
2021-08-13
Start date
2020-07-01
Completion date
2021-06-30
Last updated
2022-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Daily Activities, Near Vision, Presbyopia, Reading

Keywords

activities of daily living, presbyopia, light temperature, light intensity

Brief summary

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

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

Interventions

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

Sponsors

Democritus University of Thrace
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Screwdriver Test (ST) scorethrough study completion, an average of 6 monthsPatient 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. \[scale's best value: 100, scale's worst value: 0\]
Reading Computer Screen (RCS) scorethrough study completion, an average of 6 monthsPatient 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) scorethrough study completion, an average of 6 monthsPatient 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. \[scale's best value: 100, scale's worst value: 0\]
Subtitles Reading (SubRe) scorethrough study completion, an average of 6 monthsPatient 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. \[scale's best value: 100, scale's worst value: 0\]
Open Door Test (ODT) scorethrough study completion, an average of 6 monthsPatient 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. \[scale's best value: 100, scale's worst value: 0\]
Phone Book Search (PBS) scorethrough study completion, an average of 6 monthsPatient 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. \[scale's best value: 100, scale's worst value: 0\]
Supermarket Receipt (SupRe) scorethrough study completion, an average of 6 monthsPatient 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. \[scale's best value: 100, scale's worst value: 0\]
Book Reading (BR) scorethrough study completion, an average of 6 monthsPatient 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 message (CM) scorethrough study completion, an average of 6 monthsPatient 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. \[scale's best value: 100, scale's worst value: 0\]
Cellular Entry Search (CES) scorethrough study completion, an average of 6 monthsPatient 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. \[scale's best value: 100, scale's worst value: 0\]

Secondary

MeasureTime frameDescription
Uncorrected Intermediate Visual Acuity (UIVA)through study completion, an average of 6 monthsMonocular and binocular UIVA of all groups is estimated using web-based Democritus Digital Acuity Reading Test (wDDART)
Uncorrected Near Visual Acuity (UNVA)through study completion, an average of 6 monthsMonocular and binocular UNVA of all groups is estimated using web-based Democritus Digital Acuity Reading Test (wDDART)
25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) scorethrough study completion, an average of 6 monthsVision-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.
Uncorrected Distance Visual Acuity (UDVA)through study completion, an average of 6 monthsMonocular and binocular UDVA of all groups is estimated using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026