EDOF vs Enhanced vs Monofocal IOLs After Bilateral Cataract Surgery

Expanding Visual Horizons: Comparative Outcomes of a Novel Extended Depth-of-Focus IOL Versus Enhanced and Standard Monofocal IOLs

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.

Study Overview

• Status: Completed
• Conditions: Age-related Cataract

Detailed Description

Patients undergoing bilateral phacoemulsification for age-related cataract received one of three IOLs in both eyes: Tecnis ZCB00 (monofocal), Tecnis Eyhance ICB00 (enhanced monofocal), or Asqelio EDOF ETLIO130C (EDOF). Follow-up examinations were performed at 1 day, 1 week, 1 month, 3 months, and 6 months. The 6-month assessment included monocular and binocular visual acuity at distance (6 m), intermediate (66 cm), and near (40 cm), manifest and objective refraction, binocular defocus curves (+1.00 D to -2.50 D in 0.50 D steps), and patient questionnaires (NEI-RQL-42 glare items; custom spectacle independence and satisfaction survey).

• Study Type: Observational
• Enrollment (Actual): 197

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Adapazarı
    • Sakarya, Adapazarı, Turkey (Türkiye), 54140
      • Sakarya Yenikent State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Monofocal IOL; Tecnis ZCB00 (Johnson & Johnson Vision)
Enhanced monofocal IOL; Tecnis Eyhance ICB00 (Johnson & Johnson Vision)
EDOF IOL; Asqelio EDOF ETLIO130C (AST Products)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Monocular UDVA, UIVA, UNVA (logMAR); Monocular and binocular corrected visual acuity (CDVA, CIVA, CNVA) (logMAR)	6 months
Objective refraction	Manifest and objective refraction (spherical equivalent) (Diyoptri)	6 months
Defocus curve	Binocular defocus curve performance (+1.00 D to -2.50 D) (diyoptri)	6 months
Photic phenomena	Halo and glare scores (NEI-RQL-42 items 17 and 38; (0-100 scale)	6 months

Collaborators and Investigators

• Sponsor: Sakarya Yenikent State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): February 25, 2024
• Study Completion (Actual): January 20, 2025

Study Registration Dates

• First Submitted: February 28, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Patient satisfaction; Intraocular lens; Visual acuity; CATARACT SURGERY; Extended depth-of-focus; DEFOCUS CURVE; Enhanced monofocal
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Satisfaction
• Other Study ID Numbers: 2022/294

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No