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NCT Number: NCT07439835

Evaluation of the Visual Acuity Curves of an Enhanced Monofocal Intraocular Lens

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.

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Key information

Conditions

Presbyopia Cataract Eye Diseases Eye Neoplasms Hemic and Lymphatic Diseases IOL, Cataract Immune System Diseases Immunoproliferative Disorders Intraocular Lymphoma Lens Diseases Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Refractive Errors

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Alexandroupolis, Alexandroupolis, Evros 68100

Alexandroupoli, Evros, 68100, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Phacoemulsification with enhanced monofocal IOLs

Procedure

Uneventful pseudophakic presbyopic correction with the enhanced monofocal IOL TECNIS® Eyhance ICB00 (Johnson & Johnson Vision, USA)

Primary outcomes

  1. 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

  2. Area of the Visual Acuity Curve (AoC) assessment

    Time frame: 3 months postoperatively

    Calculation of the AoC as a visual outcome measure

  3. 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)

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

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

Acronym: IOL-VAC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2026
Registry last updated
Feb 27, 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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