Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:32 AM
Study NCT ID:
NCT07439835
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Visual Acuity Curves of an Enhanced Monofocal Intraocular Lens
Sponsor:
Democritus University of Thrace
Organization:
Study Overview
Official Title:
Evaluation of the Visual Acuity Curves of an Enhanced Monofocal Intraocular Lens: A Prospective Study
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IOL-VAC
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: