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

D

Democritus University of Thrace

Status

Completed

Conditions

Daily Activities
Presbyopia
Near Vision
Reading

Treatments

Other: ADL performance

Study type

Observational

Funder types

Other

Identifiers

NCT05005624
DUTH/EHDE9/29-5-2020

Details and patient eligibility

About

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.

Full 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

Enrollment

60 patients

Sex

All

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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