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

Completed

• Conditions: Presbyopia; Daily Activities; Near Vision; Reading
• Interventions: Other: ADL performance

• Registration Number: NCT05005624
• Lead Sponsor: Democritus University of Thrace

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

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2020-12-23
• Study Completion: 2021-06-30
• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-13
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Validation group 3 (VG-3)	ADL performance	20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.7 logMAR (Snellen 20/100)
Validation group 1 (VG-1)	ADL performance	20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.1 logMAR (Snellen 20/25)
Validation group 2 (VG-2)	ADL performance	20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.4 logMAR (Snellen 20/50)

Primary Outcome Measures

Name	Time	Method
Supermarket Receipt (SupRe) score	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.; \[scale's best value: 100, scale's worst value: 0\]
Open Door Test (ODT) score	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.; \[scale's best value: 100, scale's worst value: 0\]
Screwdriver Test (ST) score	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.; \[scale's best value: 100, scale's worst value: 0\]
Book Reading (BR) score	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.; \[scale's best value: 100, scale's worst value: 0\]
Cellular Entry Search (CES) score	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.; \[scale's best value: 100, scale's worst value: 0\]
Phone Book Search (PBS) score	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.; \[scale's best value: 100, scale's worst value: 0\]
Subtitles Reading (SubRe) score	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.; \[scale's best value: 100, scale's worst value: 0\]
Cellular message (CM) score	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.; \[scale's best value: 100, scale's worst value: 0\]
Reading Computer Screen (RCS) score	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.; \[scale's best value: 100, scale's worst value: 0\]
Drops bottle Reading (DR) score	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.; \[scale's best value: 100, scale's worst value: 0\]

Secondary Outcome Measures

Name	Time	Method
Uncorrected Intermediate Visual Acuity (UIVA)	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)
25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) score	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.
Uncorrected Distance Visual Acuity (UDVA)	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
Uncorrected Near Visual Acuity (UNVA)	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)

Trial Locations

Locations (1)

Department of Ophthalmology, University Hospital of Alexandroupolis; 🇬🇷 Alexandroupolis, Evros, Greece