Evaluation of the Visual Acuity Curves of an Enhanced Monofocal Intraocular Lens (IOL-VAC)

February 23, 2026 updated by: Georgios Labiris, Democritus University of Thrace

Evaluation of the Visual Acuity Curves of an Enhanced Monofocal Intraocular Lens: A Prospective Study

The primary objective of this study is to evaluate postoperative visual acuity curves in pseudophakic patients following unilateral or bilateral implantation of the enhanced monofocal TECNIS Eyhance IOL, using the DDARTVC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present study aims to identify the exact points of the visual acuity curve, in which the enhanced monofocal TECNIS Eyhance IOL exhibit the optimal visual performance. Specifically, the study takes into account that the validated digital acuity chart DDARTVC assesses visual acuity under real-life conditions at nine discrete distances (25, 28, 33, 40, 50, 60, 100, 200, and 300 cm), rather than through simulated defocus values. Moreover, spline curve fitting was applied to the measured data points to generate continuous visual acuity curves, enabling estimation of visual performance across the full range of distances, rather than only at the predefined measurement points.

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Presbyopic patients who underwent pseudophakic presbyopic correction with the enhanced monofocal IOL Eyhance

Description

Inclusion Criteria:

  • age between 45 to 75 years

Exclusion Criteria:

  • astigmatism >1.00 diopters
  • glaucoma
  • former incisional eye surgery
  • corneal or fundus disease
  • diabetes mellitus
  • autoimmune diseases
  • neurological or psychiatric diseases
  • posterior capsule rupture or lens misalignment
  • postoperative uncorrected distance visual acuity < 8/10.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pseuophakic patients with enhanced monofocal IOL bilateral or unilateral implantation
Patients who underwent uneventful pseudophakic presbyopic correction with the enhanced monofocal IOL TECNIS® Eyhance ICB00 (Johnson & Johnson Vision, USA)
Procedure: Phacoemulsification with enhanced monofocal IOLs
Uneventful pseudophakic presbyopic correction with the enhanced monofocal IOL TECNIS® Eyhance ICB00 (Johnson & Johnson Vision, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uncorrected Visual Acuity assessment
Time Frame: 3 months postoperatively
Visual acuity assessment in 9 discrete distances (25, 28, 33, 40, 50, 60, 100, 200, and 300 cm) using the DDARTVC chart
3 months postoperatively
Area of the Visual Acuity Curve (AoC) assessment
Time Frame: 3 months postoperatively
Calculation of the AoC as a visual outcome measure
3 months postoperatively
Vision-Related Quality of Life
Time Frame: 3 months postoperatively
the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25)
3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Democritus University of Thrace

Investigators

  • Principal Investigator: Georgios Labiris, Professor, University Hospital of Alexandroupolis, Alexandroupolis, Evros 68100

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

July 20, 2025

Study Completion (Actual)

December 15, 2025

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ES3/Th5/03-02-2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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