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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07548294

Enrollment

197

Registered

2026-04-23

Start date

2022-01-05

Completion date

2025-01-20

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Cataract

Keywords

CATARACT SURGERY, DEFOCUS CURVE, Extended depth-of-focus, Enhanced monofocal, Visual acuity, Patient satisfaction, Intraocular lens

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.

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Visual Outcomes	6 months	* 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
Patient satisfaction score	postoperative 6 months	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).

Secondary

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

Countries

Turkey (Türkiye)

Outcome results