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

Sponsor
Democritus University of Thrace (Other)
Overall Status
Recruiting
CT.gov ID
NCT04739085
Collaborator
(none)
100
1
5.9
16.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Nov 20, 2020
Anticipated Primary Completion Date :
Mar 20, 2021
Anticipated Study Completion Date :
May 20, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Ophthalmology, University Hospital of Alexandroupolis Alexandroupolis Evros Greece 68100

Sponsors and Collaborators

  • Democritus University of Thrace

Investigators

  • Study Chair: Georgios Labiris, MD, PhD, Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Georgios Labiris, Professor (Associate) of Democritus University of Thrace, Democritus University of Thrace
ClinicalTrials.gov Identifier:
NCT04739085
Other Study ID Numbers:
  • ES1/Th4/21-1-2021
First Posted:
Feb 4, 2021
Last Update Posted:
Feb 4, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Georgios Labiris, Professor (Associate) of Democritus University of Thrace, Democritus University of Thrace
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 4, 2021