NCT07439835

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

February 23, 2026

Last Update Submit

February 23, 2026

Conditions

PresbyopiaIOL, Cataract

Keywords

pseudophakic presbyopic correctionenhanced monofocal intraocular lensdefocus curvesvisual curvesdigital optotype

Outcome Measures

Primary Outcomes (3)

  • Uncorrected Visual Acuity assessment

    Visual acuity assessment in 9 discrete distances (25, 28, 33, 40, 50, 60, 100, 200, and 300 cm) using the DDARTVC chart

    3 months postoperatively

  • Area of the Visual Acuity Curve (AoC) assessment

    Calculation of the AoC as a visual outcome measure

    3 months postoperatively

  • Vision-Related Quality of Life

    the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25)

    3 months postoperatively

Study Arms (1)

Pseuophakic patients with enhanced monofocal IOL bilateral or unilateral implantation

Patients who underwent uneventful pseudophakic presbyopic correction with the enhanced monofocal IOL TECNIS® Eyhance ICB00 (Johnson \& Johnson Vision, USA)

Procedure: Phacoemulsification with enhanced monofocal IOLs

Interventions

Phacoemulsification with enhanced monofocal IOLsPROCEDURE

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

Pseuophakic patients with enhanced monofocal IOL bilateral or unilateral implantation

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Presbyopic patients who underwent pseudophakic presbyopic correction with the enhanced monofocal IOL Eyhance

You may qualify if:

  • age between 45 to 75 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Alexandroupolis, Alexandroupolis, Evros 68100

Alexandroupoli, Evros, 68100, Greece

Location

Related Publications (3)

  • Labiris 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: 41156017BACKGROUND

  • Labiris 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: 36853857BACKGROUND

  • Labiris 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: 37847127BACKGROUND

MeSH Terms

Conditions

PresbyopiaIntraocular LymphomaCataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesLymphomaNeoplasms by Histologic TypeNeoplasmsEye NeoplasmsNeoplasms by SiteLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Georgios Labiris, Professor

    University Hospital of Alexandroupolis, Alexandroupolis, Evros 68100

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

February 23, 2026

First Posted

February 27, 2026

Study Start

April 1, 2024

Primary Completion

July 20, 2025

Study Completion

December 15, 2025

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

GR(1)