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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 40 to 75 years
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Study population: Normophakic participants with a clear natural lens

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Presbyopia, Near Vision, Reading, Daily Activities

Being tested

ADL performance

Keywords

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

Medical subject headings

Presbyopia, Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• ADL performanceOther

  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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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]

   Measured: through study completion, an average of 6 months

2. 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]

   Measured: through study completion, an average of 6 months

3. 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]

   Measured: through study completion, an average of 6 months

4. 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]

   Measured: through study completion, an average of 6 months

5. 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]

   Measured: through study completion, an average of 6 months

6. 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]

   Measured: through study completion, an average of 6 months

7. 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]

   Measured: through study completion, an average of 6 months

8. 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]

   Measured: through study completion, an average of 6 months

9. 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]

   Measured: through study completion, an average of 6 months

10. 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]

    Measured: through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted13 Aug 2021
2. Study start1 Jul 2020
3. Primary completion23 Dec 2020
4. Study completion30 Jun 2021

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for PresbyopiaStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.