Clinical trial NCT05005624: Validation of an Activities-of-daily-living Framework at Different Light Conditions
Official title: Validation of an Activities-of-daily-living Framework at Different Combinations of Light Temperature and Light Intensity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Presbyopia
Near Vision
Reading
Daily Activities
Keywords: activities of daily living
presbyopia
light temperature
light intensity
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Normophakic participants with a clear natural lens

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

Eligibility criteria: 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

Primary outcomes:
measure: Phone Book Search (PBS) score
timeFrame: through study completion, an average of 6 months
measure: Supermarket Receipt (SupRe) score
timeFrame: through study completion, an average of 6 months
measure: Book Reading (BR) score
timeFrame: through study completion, an average of 6 months
measure: Cellular message (CM) score
timeFrame: through study completion, an average of 6 months
measure: Cellular Entry Search (CES) score
timeFrame: through study completion, an average of 6 months
measure: Reading Computer Screen (RCS) score
timeFrame: through study completion, an average of 6 months
measure: Drops bottle Reading (DR) score
timeFrame: through study completion, an average of 6 months
measure: Subtitles Reading (SubRe) score
timeFrame: through study completion, an average of 6 months
measure: Open Door Test (ODT) score
timeFrame: through study completion, an average of 6 months
measure: Screwdriver Test (ST) score
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Uncorrected Distance Visual Acuity (UDVA)
timeFrame: through study completion, an average of 6 months
measure: Uncorrected Intermediate Visual Acuity (UIVA)
timeFrame: through study completion, an average of 6 months
measure: Uncorrected Near Visual Acuity (UNVA)
timeFrame: through study completion, an average of 6 months
measure: 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) score
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Department of Ophthalmology, University Hospital of Alexandroupolis
state: Evros
Study officials:
affiliation: Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
name: Georgios Labiris, MD, PhD
role: STUDY_CHAIR
References: