NCT07548294

Brief Summary

Consecutive comparative case series evaluating visual outcomes and patientreported satisfaction after bilateral cataract surgery with implantation of the same IOL type (standard monofocal, enhanced monofocal, or novel EDOF IOL). Outcomes assessed at 6 months included uncorrected visual acuity at distance, intermediate, and near; refraction; defocus curves; and questionnaires on halos, glare, and spectacle independence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

February 28, 2026

Last Update Submit

April 21, 2026

Conditions

Age-related Cataract

Keywords

CATARACT SURGERYDEFOCUS CURVEExtended depth-of-focusEnhanced monofocalVisual acuityPatient satisfactionIntraocular lens

Outcome Measures

Primary Outcomes (2)

  • Visual Outcomes

    * Binocular uncorrected distance visual acuity (UDVA) at 6 m, logMAR * Binocular uncorrected intermediate visual acuity (UIVA) at 66 cm, logMAR * Binocular uncorrected near visual acuity (UNVA) at 40 cm, logMAR

    6 months

  • Patient satisfaction score

    The patients were asked about their satisfaction with the refractive outcome, as used in International Multicenter Concerto Study as follows: How satisfied are you with your spectacle-free vision at far/intermediate/near distance? The answer choices ranged from 0 (not at all satisfied) to 10 (very satisfied).

    postoperative 6 months

Secondary Outcomes (4)

  • Visual acuity

    6 months

  • Objective refraction

    6 months

  • Defocus curve

    6 months

  • Photic phenomena

    6 months

Study Arms (3)

Monofocal IOL

Tecnis ZCB00 (Johnson \& Johnson Vision)

Enhanced monofocal IOL

Tecnis Eyhance ICB00 (Johnson \& Johnson Vision)

EDOF IOL

Asqelio EDOF ETLIO130C (AST Products)

Eligibility Criteria

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

All sex, Ages: 45-75 years, Healthy Volunteers: No

You may qualify if:

  • Age-related cataract in both eyes
  • Eligible for bilateral IOL implantation
  • Willingness to return for scheduled follow-up

You may not qualify if:

  • Preoperative corneal astigmatism \> 1.0 D
  • Axial length \>21 mm or \<26 mm
  • Previous intraocular or corneal surgery
  • Ocular comorbidities affecting vision (severe dry eye, amblyopia, ocular surface disease, corneal pathology, retinal diseases, uveitis, glaucoma, pseudoexfoliation, pterygium)
  • Intraoperative or postoperative complications, or failure to complete 6-month follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya Yenikent State Hospital

Sakarya, Adapazarı, 54140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Head of Ophthalmology Department

Study Record Dates

First Submitted

February 28, 2026

First Posted

April 23, 2026

Study Start

January 5, 2022

Primary Completion

February 25, 2024

Study Completion

January 20, 2025

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)