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CompletedNCT06460389Updated Feb 24, 2026

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

An observational study in Presbyopia, Pseudophakia and Cataract, sponsored by Democritus University of Thrace. Completed at 1 site in Greece. Open to participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by Democritus University of Thrace · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
45 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Presbyopia
  • Pseudophakia
  • Cataract
  • Refractive Errors

Keywords

  • pseudophakic presbyopic correction
  • extended depth of field intraocular lenses
  • visual curve
  • visual acuity
03

In context

Presbyopia

336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's enrollment of 40 is below the median of 88 across 52 observational studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

Democritus University of Thrace is the lead sponsor of 70 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Inability to understand the Greek language and respond to the interview
  • conditions of the posterior or corneal segment
  • glaucoma
  • previous intraocular surgery
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testVisual 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).

06

What researchers measure

Primary outcomes

  1. Visual acuity assessment

    Visual acuity assessment in 9 focal points using DDART chart

    Time frame: 4 months

  2. Area of the curve (AOC) assessment

    Calculation of the AOC as a visual outscome measure

    Time frame: 4 months

  3. 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)

    Time frame: 4 months

07

Study locations

1 site
  • Department of Ophthalmology, University Hospital of Alexandroupolis
    Alexandroupoli, Evros 68100, Greece
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2024 to primary completion in Nov 2024, 10 months.

Of 25 non-industry observational studies under Presbyopia, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's 10 months is close to that.

Counting every sponsor, half of 35 studies reached it within 11 months; a quarter within 5 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 11, 2024
First posted
Jun 14, 2024
StartActual
Jan 1, 2024
Primary completionActual
Nov 30, 2024
CompletionActual
Dec 31, 2024
Last update
Feb 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06460389
Lead sponsor
Democritus University of Thrace
Responsible party
Georgios Labiris (Professor (Associate) of Democritus University of Thrace, Democritus University of Thrace) — Principal investigator
First posted
Jun 14, 2024
Start date
Jan 1, 2024
Primary completion
Nov 30, 2024
Completion
Dec 31, 2024
Last update
Feb 24, 2026

Study contacts

Georgios Labiris
study chair · Democritus University of Thrace

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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