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OpenTrials
Completed

NCT Number: NCT06460389

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.

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Visual acuity assessment

    Time frame: 4 months

    Visual acuity assessment in 9 focal points using DDART chart

  2. Area of the curve (AOC) assessment

    Time frame: 4 months

    Calculation of the AOC as a visual outscome measure

  3. the degree of subjective satisfaction of the patient

    Time frame: 4 months

    the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25)

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2024
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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