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Visual Outcomes After Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance

Comparison of Visual Outcomes After Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06460389
Enrollment
40
Registered
2024-06-14
Start date
2024-01-01
Completion date
2024-12-31
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Presbyopia, Pseudophakia, Refractive Errors

Keywords

pseudophakic presbyopic correction, extended depth of field intraocular lenses, visual curve, visual acuity

Brief summary

The primary objective of this study is to compare the postoperative visual acuity curves of patients that underwent one of the following surgical procedures: Insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance.

Detailed description

This is a prospective, comparative study of 60 patients diagnosed with grade 2 cataracts (according to LOCS III) that underwent one of the following surgical procedures: Insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance. In these patients, a comparison of postoperative visual acuity curves of both groups will be conducted. Visual acuity curves will be designed using the validated digital optotype Democritus Digital Acuity & Reading Test (DDART). Assessment of visual acuity will be performed at 9 different distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm). Overall visual acuity curves and the area under the curve will be formed through the application as the primary means of evaluating visual capacity. Additionally, the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25). All examinations will be conducted according to standard clinical practice.

Interventions

Uncorrected visual acuity for nine distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm) examination via a Democritus Digital Acuity \& Reading Test (DDART).

Sponsors

Democritus University of Thrace
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Diagnosis of grade 2 cataracts (according to LOCS III) * age \>45 years.

Exclusion criteria

* Inability to understand the Greek language and respond to the interview * conditions of the posterior or corneal segment * glaucoma * previous intraocular surgery

Design outcomes

Primary

MeasureTime frameDescription
Visual acuity assessment4 monthsVisual acuity assessment in 9 focal points using DDART chart
Area of the curve (AOC) assessment4 monthsCalculation of the AOC as a visual outscome measure
the degree of subjective satisfaction of the patient4 monthsthe degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25)

Countries

Greece

Contacts

STUDY_CHAIRGeorgios Labiris

Democritus University of Thrace

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026