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

NCT06460389 | Completed

• 1 other identifier: ES6/Th11/14-03-2024
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia; Pseudophakia; Cataract; Refractive Errors

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

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

Interventions

Visual Acuity Assessment DIAGNOSTIC_TEST

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 with digital assistance; Insertion of an extended depth of focus intraocular lens without digital assistance

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location

MeSH Terms

Conditions

Presbyopia; Pseudophakia; Cataract; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lens Diseases

Study Officials

• Georgios Labiris

  Democritus University of Thrace

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: January 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

GR (1)