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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05005624
• Other study ID #: DUTH/EHDE9/29-5-2020
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2022
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2021
• Est. primary completion date: December 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Daily Activities
• Near Vision
• Presbyopia
• Reading

Intervention

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

Locations

Country	Name	City	State
Greece	Department of Ophthalmology, University Hospital of Alexandroupolis	Alexandroupolis	Evros

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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