Clinical trial NCT04739085: Level of Agreement Between Clinical Defocus Curves and the Web-based Democritus Digital Acuity Reading Test wDDART
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Presbyopia
Near Vision
Keywords: defocus curves
multifocal IOL implantation
wDDART
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 \[bifocal hybrid IOL (Restor +2.50 diopters, Alcon) in the dominant eye and trifocal diffractive IOL (Panoptix, Alcon) in the recessive eye\]

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.

Eligibility criteria: 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

Primary outcomes:
measure: Distance-corrected near visual acuity (DCNVA) at 30 cm via defocus curves
timeFrame: through study completion, 6 months
measure: Distance-corrected near visual acuity (DCNVA) at 40 cm via defocus curves
timeFrame: through study completion, 6 months
measure: Distance-corrected intermediate visual acuity (DCIVA) at 60 cm via defocus curves
timeFrame: through study completion, 6 months
measure: Distance-corrected intermediate visual acuity (DCIVA) at 80 cm via defocus curves
timeFrame: through study completion, 6 months
measure: Distance-corrected near visual acuity (DCNVA) at 30 cm via wDDART
timeFrame: through study completion, 6 months
measure: Distance-corrected near visual acuity (DCNVA) at 40 cm via wDDART
timeFrame: through study completion, 6 months
measure: Distance-corrected intermediate visual acuity (DCIVA) at 60 cm via wDDART
timeFrame: through study completion, 6 months
measure: Distance-corrected intermediate visual acuity (DCIVA) at 80 cm via wDDART
timeFrame: through study completion, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Department of Ophthalmology, University Hospital of Alexandroupolis
state: Evros
Study officials:
affiliation: Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
name: Georgios Labiris, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.