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

• Conditions: Near Vision; Presbyopia
• Interventions: Diagnostic Test: Defocus curves - Monocular distance visual acuity with trial lenses added to the best correction for distance; Diagnostic Test: wDDART - Monocular near visual acuity using the best correction for distance

• Registration Number: NCT04739085
• Lead Sponsor: Democritus University of Thrace

Brief 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.

Study Timeline

• Study Start: 2020-11-20
• Status Verified: 2021-01
• Study First Submitted: 2021-01-31
• Study First Submitted QC: 2021-01-31
• Last Update Submitted: 2021-01-31
• Study First Posted: 2021-02-04
• Last Update Posted: 2021-02-04
• Primary Completion: 2021-03-20
• Study Completion: 2021-05-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Previous cataract lens extraction, age> 40 years, monocular best corrected distance visual acuity > 7/10

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Exclusion Criteria

• Glaucoma, corneal diseases, macular diseases, postoperative opacification of the posterior capsule, former mental diseases

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Defocus curve group	Defocus curves - Monocular distance visual acuity with trial lenses added to the best correction for distance	The 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 the distances of 30 cm, 40 cm, 60 cm, and 80 cm, respectively.
wDDART group	wDDART - Monocular near visual acuity using the best correction for distance	The 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.

Primary Outcome Measures

Name	Time	Method
Distance-corrected near visual acuity (DCNVA) at 30 cm via defocus curves	through study completion, 6 months	The monocular distance visual acuity of each participant's eye is evaluated using a trial lens of -3.00 sph (added to the best correction for distance), which corresponds to the distance of 30 cm
Distance-corrected intermediate visual acuity (DCIVA) at 80 cm via defocus curves	through study completion, 6 months	The monocular distance visual acuity of each participant's eye is evaluated using a trial lens of -1.25 sph (added to the best correction for distance), which corresponds to the distance of 80 cm
Distance-corrected near visual acuity (DCNVA) at 30 cm via wDDART	through study completion, 6 months	The monocular near (30 cm) visual acuity of each participant's eye is evaluated using the best correction for distance
Distance-corrected intermediate visual acuity (DCIVA) at 60 cm via wDDART	through study completion, 6 months	The monocular intermediate (60 cm) visual acuity of each participant's eye is evaluated using the best correction for distance
Distance-corrected near visual acuity (DCNVA) at 40 cm via defocus curves	through study completion, 6 months	The monocular distance visual acuity of each participant's eye is evaluated using a trial lens of -2.50 sph (added to the best correction for distance), which corresponds to the distance of 40 cm
Distance-corrected intermediate visual acuity (DCIVA) at 60 cm via defocus curves	through study completion, 6 months	The monocular distance visual acuity of each participant's eye is evaluated using a trial lens of -1.75 sph (added to the best correction for distance), which corresponds to the distance of 60 cm
Distance-corrected near visual acuity (DCNVA) at 40 cm via wDDART	through study completion, 6 months	The monocular near (40 cm) visual acuity of each participant's eye is evaluated using the best correction for distance
Distance-corrected intermediate visual acuity (DCIVA) at 80 cm via wDDART	through study completion, 6 months	The monocular intermediate (80 cm) visual acuity of each participant's eye is evaluated using the best correction for distance

Trial Locations

Locations (1)

Department of Ophthalmology, University Hospital of Alexandroupolis; 🇬🇷 Alexandroupolis, Evros, Greece