NCT07439835

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: Democritus University of Thrace · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Presbyopia
• IOL, Cataract

Interventions

Type	Name	Description
PROCEDURE	Phacoemulsification with enhanced monofocal IOLs	Uneventful pseudophakic presbyopic correction with the enhanced monofocal IOL TECNIS® Eyhance ICB00 (Johnson \& Johnson Vision, USA)

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-07-20
• Completion: 2025-12-15
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Greece