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

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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Cataract; Presbyopia; Pseudophakia
• Intervention / Treatment: Diagnostic test: Visual Acuity Assessment

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Greece
  • Evros
    • Alexandroupoli, Evros, Greece, 68100
      • Department of Ophthalmology, University Hospital of Alexandroupolis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants that underwent Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Insertion of an extended depth of focus intraocular lens with digital assistance; Participants that underwent uncomplicated IOL implantation of an extended depth of focus intraocular lens with digital assistance	Diagnostic test: Visual Acuity Assessment; 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).
Insertion of an extended depth of focus intraocular lens without digital assistance; Participants that underwent uncomplicated IOL implantation of an extended depth of focus intraocular lens without digital assistance	Diagnostic test: Visual Acuity Assessment; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity assessment	Visual acuity assessment in 9 focal points using DDART chart	4 months
Area of the curve (AOC) assessment	Calculation of the AOC as a visual outscome measure	4 months
the degree of subjective satisfaction of the patient	the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25)	4 months

Collaborators and Investigators

• Sponsor: Democritus University of Thrace
• Investigators: Study Chair: Georgios Labiris, Democritus University of Thrace

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: visual acuity; pseudophakic presbyopic correction; extended depth of field intraocular lenses; visual curve
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cataract; Presbyopia; Refractive Errors; Pseudophakia
• Other Study ID Numbers: ES6/Th11/14-03-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No