Clinical trial · Observational
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
NCT07439835CI-TRIAL-00104149IOL-VACcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| IOL, Cataract | — | UNRESOLVED | — |
| Presbyopia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phacoemulsification with enhanced monofocal IOLs | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pseuophakic patients with enhanced monofocal IOL bilateral or unilateral implantation
- description
- Patients who underwent uneventful pseudophakic presbyopic correction with the enhanced monofocal IOL TECNIS® Eyhance ICB00 (Johnson \& Johnson Vision, USA)
- interventionNames
- Procedure: Phacoemulsification with enhanced monofocal IOLs
Primary outcomes (3)
- measure
- Uncorrected Visual Acuity assessment
- timeFrame
- 3 months postoperatively
- description
- Visual acuity assessment in 9 discrete distances (25, 28, 33, 40, 50, 60, 100, 200, and 300 cm) using the DDARTVC chart
- measure
- Area of the Visual Acuity Curve (AoC) assessment
- timeFrame
- 3 months postoperatively
- description
- Calculation of the AoC as a visual outcome measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDLabiris G, Panagis C, Mitsi C, Panagiotopoulou EK, Vorgiazidou E, Delibasis KK, Bakirtzis M. Enhancing Postoperative Evaluation of Presbyopia Corrections: Correlation of Visual Curve Indices with Vision-Related Quality of Life. J Clin Med. 2025 Oct 10;14(20):7149. doi: 10.3390/jcm14207149. PMID 41156017
- BACKGROUNDLabiris G, Panagiotopoulou EK, Delibasis K, Duzha E, Bakirtzis M, Panagis C, Boboridis K, Mokka A, Balidis M, Damtsi C, Ntonti P. Validation of a web-based distance visual acuity test. J Cataract Refract Surg. 2023 Jul 1;49(7):666-671. doi: 10.1097/j.jcrs.0000000000001176. PMID 36853857
- BACKGROUNDLabiris G, Panagis C, Ntonti P, Konstantinidis A, Bakirtzis M. Mix-and-match vs bilateral trifocal and bilateral EDOF intraocular lens implantation: the spline curve battle. J Cataract Refract Surg. 2024 Feb 1;50(2):167-173. doi: 10.1097/j.jcrs.0000000000001336. PMID 37847127