NCT04618224

Development and Validation of an Internet-based Near and Intermediate-vision Reading Test

Introduction of an Internet-based Near and Intermediate-vision Reading Test for Greek-speaking Normal and Low Vision Adults (wDDART): Development and Validation.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Democritus University of Thrace · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Primary objective of our study is to develop and validate an internet-based digital near and intermediate-vision reading test in the greek language.

Detailed description

Present study aims to develop and validate a computer-based digital near-vision reading test (web Democritus Digital Acuity Reading Test - wDDART) based on the validated digital DDART. Specifically, present study aims to develop a new online reading test (wDDART) based on the corresponding digital DDART reading test for Windows and to evaluate the level of agreement between the two reading tests, as well as test-retest reliability of the online wDDART reading test. The first part of the study is the development of the online reading test, which will include the following new smart features: 1. Automatic calculation of the reading time of each sentence (each logMAR) 2. Automatic calculation of the basic reading parameters - RA, MRS, CPS, ACC - immediately after the completion of the examination 3. Adjustment of the font size according to the size of the computer screen used for the examination 4. Real time calculation of the patient-screen distance through a face detection system The second part of this study is the clinical validation of the online wDDART reading test. In this part, four reading parameters measured with the digital and the online version are compared. These parameters are the following: 1. Reading Acuity (RA) 2. Maximum Reading Speed (MRS) 3. Critical Print Size (CPS) 4. Accessibility Index (ACC) All the comparisons take place in two groups: a) a Normal Vision Group (NVG), and b) a Low Vision Group (LVG) in order to estimate the reading capacity in a population with a wide range of vision.

Conditions

• Presbyopia
• Refractive Errors
• Low Vision
• Near Vision
• Reading

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	DDART Testing	One randomly selected eye is included for each study participant. Participants respond to the DDART near vision test with defined environmental conditions at 40 cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.
DIAGNOSTIC_TEST	wDDART Testing	One randomly selected eye is included for each study participant. Participants respond to the wDDART near vision test with defined environmental conditions at 40 cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.

Timeline

• Start date: 2020-12-02
• Primary completion: 2021-01-15
• Completion: 2021-02-10
• First posted: 2020-11-05
• Last updated: 2021-02-16

Locations

2 sites across 1 country: Greece