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

NCT05005624 | Completed DMC

• 1 other identifier: DUTH/EHDE9/29-5-2020
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia; Near Vision; Reading; Daily Activities

Keywords

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

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (4)

• Uncorrected Distance Visual Acuity (UDVA)

  through study completion, an average of 6 months

• Uncorrected Intermediate Visual Acuity (UIVA)

  through study completion, an average of 6 months

• Uncorrected Near Visual Acuity (UNVA)

  through study completion, an average of 6 months

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

  through study completion, an average of 6 months

Study Arms (3)

Validation group 1 (VG-1)

20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.1 logMAR (Snellen 20/25)

Other: ADL performance

Validation group 2 (VG-2)

20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.4 logMAR (Snellen 20/50)

Other: ADL performance

Validation group 3 (VG-3)

20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.7 logMAR (Snellen 20/100)

Other: ADL performance

Interventions

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: 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 1 (VG-1); Validation group 2 (VG-2); Validation group 3 (VG-3)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Normophakic participants with a clear natural lens

You may qualify if:

• normophakic participants with a clear natural lens
• age between 40 to 75 years old
• UNVA: logMAR 0.1, 0.4, or 0.7

You may not qualify if:

• 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

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location

MeSH Terms

Conditions

Presbyopia; Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Georgios Labiris, MD, PhD

  Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Associate) of Democritus University of Thrace

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 13, 2021
• Study Start: July 1, 2020
• Primary Completion: December 23, 2020
• Study Completion: June 30, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-04

Locations

GR (1)