Skip to main content
OpenTrials
Completed

NCT Number: NCT05005624

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Presbyopia Daily Activities Eye Diseases Myopia Near Vision Reading Refractive Errors

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADL performance

Other

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:

  • 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

Primary outcomes

  1. Phone Book Search (PBS) score

    Time frame: 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]

  2. Supermarket Receipt (SupRe) score

    Time frame: 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]

  3. Book Reading (BR) score

    Time frame: 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]

  4. Cellular message (CM) score

    Time frame: 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]

  5. Cellular Entry Search (CES) score

    Time frame: 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]

  6. Reading Computer Screen (RCS) score

    Time frame: 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]

  7. Drops bottle Reading (DR) score

    Time frame: 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]

  8. Subtitles Reading (SubRe) score

    Time frame: 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]

  9. Open Door Test (ODT) score

    Time frame: 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]

  10. Screwdriver Test (ST) score

    Time frame: 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]

Secondary outcomes

  1. Uncorrected Distance Visual Acuity (UDVA)

    Time frame: through study completion, an average of 6 months

    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

  2. Uncorrected Intermediate Visual Acuity (UIVA)

    Time frame: through study completion, an average of 6 months

    Monocular and binocular UIVA of all groups is estimated using web-based Democritus Digital Acuity Reading Test (wDDART)

  3. Uncorrected Near Visual Acuity (UNVA)

    Time frame: through study completion, an average of 6 months

    Monocular and binocular UNVA of all groups is estimated using web-based Democritus Digital Acuity Reading Test (wDDART)

  4. 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) score

    Time frame: through study completion, an average of 6 months

    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.

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Aug 13, 2021
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.