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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04739085
• Other study ID #: ES1/Th4/21-1-2021
• Status: Recruiting
• Start date: November 20, 2020
• Est. completion date: May 20, 2021

Study information

• Verified date: January 2021
• Source: Democritus University of Thrace
• Contact: Georgios Labiris, MD, PhD
• Phone: 00302551030405
• Email: labiris[@]usa.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 20, 2021
• Est. primary completion date: March 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Near Vision
• Presbyopia

Intervention

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 - 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.

Locations

Country	Name	City	State
Greece	Department of Ophthalmology, University Hospital of Alexandroupolis	Alexandroupolis	Evros

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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