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

NCT04739085 | Unknown DMC

• 1 other identifier: ES1/Th4/21-1-2021
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia; Near Vision

Keywords

defocus curves; multifocal IOL implantation; wDDART

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

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

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

Interventions

Defocus curves - Monocular distance visual acuity with trial lenses added to the best correction for distance DIAGNOSTIC_TEST

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.

Defocus curve group

wDDART - Monocular near visual acuity using the best correction for distance DIAGNOSTIC_TEST

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.

wDDART group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 \[bifocal hybrid IOL (Restor +2.50 diopters, Alcon) in the dominant eye and trifocal diffractive IOL (Panoptix, Alcon) in the recessive eye\]

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

RECRUITING

Related 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.

  PMID: 33102611 BACKGROUND

MeSH Terms

Conditions

Presbyopia; Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Georgios Labiris, MD, PhD

  Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

  STUDY CHAIR

Central Study Contacts

Georgios Labiris, MD, PhD

CONTACT

00302551030405; labiris@usa.net

Eirini - Kanella Panagiotopoulou, MD

CONTACT

00306978730858; eipanagi@med.duth.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Associate) of Democritus University of Thrace

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 4, 2021
• Study Start: November 20, 2020
• Primary Completion: March 20, 2021
• Study Completion: May 20, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-01

Locations

GR (1)