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UnknownNCT04739085

Level of Agreement Between Clinical Defocus Curves and the Web-based Democritus Digital Acuity Reading Test wDDART

Level of Agreement Between Clinical Defocus Curves and the Near and Intermediate Vision Web-based Democritus Digital Acuity Reading Test wDDART: a Comparative Study

Status
Unknown
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Democritus University of Thrace · Academic / Other
Sex
All
Age
40 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The primary objective of this study is to compare the level of agreement between clinical defocus curves and the web Democritus Digital Acuity Reading Test (wDDART), which is a web-based digital near and intermediate vision reading test.

Detailed description

The 'defocus curve' assessment technique aims to simulate different distances from near to far over which the patient's visual acuity (VA) is evaluated. Defocus curves are created by first measuring best-corrected distance and near VA of the examinee. Then, a series of positive- and negative-powered trial lenses are added to the best-corrected distance visual acuity (BCDVA) of the patient's eye. Viewing through the addition of a minus lens creates divergent light rays with the same refractive effect as bringing the eye chart closer to the viewer. For instance, a -2.50 D lens represents the distance of 40 cm. The "defocus curve" assessment technique is a method used widely for the assessment of the functional vision range following multifocal intraocular lens (IOL) implantation. Since this method is a simulation of the near vision, it would be ideal if near vision could be evaluated objectively with a near vision chart. However, the conventional printed near vision charts are not available for a variety of reading distances. In addition, the measurement of near VA at different distances with a printed reading chart intended for one predefined distance (e.g. printed chart for 40 cm) and the transformation of the reading score at 40 cm to an equivalent score for the examined distances is impractical in clinical setting. For this reason, a digital reading test that allows the text calibration for all reading distances could be a practical method for the rapid and ease evaluation of the near VA, especially in patients implanted with multifocal IOLs. The web-based digital near and intermediate vision reading test wDDART offers the ability to estimate VA at different distances with automated measurement of the patient-screen distance. Therefore, the present study aims to investigate the level of agreement between clinical defocus curves and the web-based digital near and intermediate vision reading test wDDART.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTDefocus curves - Monocular distance visual acuity with trial lenses added to the best correction for distanceThe monocular distance visual acuity of each participant' eye is evaluated using trial lenses of -3.00 sph, -2.50 sph, -1.75 sph, and -1.25 sph (added to the best correction for distance), which correspond to distances 30 cm, 40 cm, 60 cm and 80 cm, respectively.
DIAGNOSTIC_TESTwDDART - Monocular near visual acuity using the best correction for distanceThe same participants undergo visual acuity test via the web-based digital near vision reading test wDDART at 30 cm, 40 cm, 60 cm and 80 cm, having their best correction for distance.

Timeline

Start date
2020-11-20
Primary completion
2021-03-20
Completion
2021-05-20
First posted
2021-02-04
Last updated
2021-02-04

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT04739085. Inclusion in this directory is not an endorsement.