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

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia; Near Vision; Reading; Daily Activities
• Intervention / Treatment: Other: ADL performance

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

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Greece
  • Evros
    • Alexandroupolis, Evros, Greece, 68100
      • Department of Ophthalmology, University Hospital of Alexandroupolis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Normophakic participants with a clear natural lens

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Validation group 1 (VG-1); 20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.1 logMAR (Snellen 20/25)	Other: 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)	Other: 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)	Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Democritus University of Thrace

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): December 23, 2020
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: activities of daily living; presbyopia; light intensity; light temperature
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: DUTH/EHDE9/29-5-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No