EDOF vs Enhanced vs Monofocal IOLs After Bilateral Cataract Surgery

Sakarya Yenikent State Hospital197 enrolled

Overview

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.

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

197

Conditions

Age-related Cataract

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Sakarya Yenikent State Hospital

Sakarya, Adapazarı, Turkey (Türkiye)

Outcomes

Primary Outcomes

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

Time frame: 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).

Time frame: postoperative 6 months

Secondary Outcomes

Visual acuity

* Monocular UDVA, UIVA, UNVA (logMAR) * Monocular and binocular corrected visual acuity (CDVA, CIVA, CNVA) (logMAR)

Time frame: 6 months

Objective refraction

Manifest and objective refraction (spherical equivalent) (Diyoptri)

Time frame: 6 months

Defocus curve

Binocular defocus curve performance (+1.00 D to -2.50 D) (diyoptri)

Time frame: 6 months

Photic phenomena

Halo and glare scores (NEI-RQL-42 items 17 and 38; (0-100 scale)

Time frame: 6 months

Data from ClinicalTrials.gov

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