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

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.

Study Overview

• Status: Unknown
• Conditions: Presbyopia; Near Vision
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Greece
  • Evros
    • Alexandroupolis, Evros, Greece, 68100
      • Recruiting
      • Department of Ophthalmology, University Hospital of Alexandroupolis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with previous cataract lens extraction will be categorized into the following groups:

1. Monofocal group
2. Monovision group (monofocal IOLs bilaterally)
3. Hybrid monovision group (monofocal IOL in the dominant eye and multifocal IOL in the recessive eye)
4. Bilateral multifocal group (the same multifocal IOLs bilaterally)
5. Premium monovision group [bifocal hybrid IOL (Restor +2.50 diopters, Alcon) in the dominant eye and trifocal diffractive IOL (Panoptix, Alcon) in the recessive eye]

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Defocus curve group; 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.	Diagnostic test: 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 distances 30 cm, 40 cm, 60 cm and 80 cm, respectively.
wDDART group; 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.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance-corrected near visual acuity (DCNVA) at 30 cm via defocus curves	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	through study completion, 6 months
Distance-corrected near visual acuity (DCNVA) at 40 cm via defocus curves	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	through study completion, 6 months
Distance-corrected intermediate visual acuity (DCIVA) at 60 cm via defocus curves	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	through study completion, 6 months
Distance-corrected intermediate visual acuity (DCIVA) at 80 cm via defocus curves	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	through study completion, 6 months
Distance-corrected near visual acuity (DCNVA) at 30 cm via wDDART	The monocular near (30 cm) visual acuity of each participant's eye is evaluated using the best correction for distance	through study completion, 6 months
Distance-corrected near visual acuity (DCNVA) at 40 cm via wDDART	The monocular near (40 cm) visual acuity of each participant's eye is evaluated using the best correction for distance	through study completion, 6 months
Distance-corrected intermediate visual acuity (DCIVA) at 60 cm via wDDART	The monocular intermediate (60 cm) visual acuity of each participant's eye is evaluated using the best correction for distance	through study completion, 6 months
Distance-corrected intermediate visual acuity (DCIVA) at 80 cm via wDDART	The monocular intermediate (80 cm) visual acuity of each participant's eye is evaluated using the best correction for distance	through study completion, 6 months

Collaborators and Investigators

• Sponsor: Democritus University of Thrace

Publications and helpful links

General Publications

• Labiris G, Panagiotopoulou EK, Chatzimichael E, Tzinava M, Mataftsi A, Delibasis K. Introduction of a digital near-vision reading test for normal and low vision adults: development and validation. Eye Vis (Lond). 2020 Oct 22;7:51. doi: 10.1186/s40662-020-00216-0. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Anticipated): March 20, 2021
• Study Completion (Anticipated): May 20, 2021

Study Registration Dates

• First Submitted: January 31, 2021
• First Submitted That Met QC Criteria: January 31, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: January 31, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: defocus curves; multifocal IOL implantation; wDDART
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: ES1/Th4/21-1-2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No