IOL, Cataract, Presbyopia
Conditions
Keywords
pseudophakic presbyopic correction, enhanced monofocal intraocular lens, defocus curves, visual curves, digital optotype
Brief 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.
Interventions
PROCEDUREPhacoemulsification with enhanced monofocal IOLs
Uneventful pseudophakic presbyopic correction with the enhanced monofocal IOL TECNIS® Eyhance ICB00 (Johnson \& Johnson Vision, USA)
Sponsors
Democritus University of Thrace
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Visual Acuity assessment | 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 |
| Area of the Visual Acuity Curve (AoC) assessment | 3 months postoperatively | Calculation of the AoC as a visual outcome measure |
| Vision-Related Quality of Life | 3 months postoperatively | the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25) |
Countries
Greece
Contacts
PRINCIPAL_INVESTIGATORGeorgios Labiris, Professor
University Hospital of Alexandroupolis, Alexandroupolis, Evros 68100
Outcome results
None listed