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Completed

NCT Number: NCT07548294

EDOF vs Enhanced vs Monofocal IOLs After Bilateral Cataract Surgery

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.

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Key information

Conditions

Age-related Cataract Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sakarya Yenikent State Hospital

Sakarya, Adapazarı, 54140, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Visual Outcomes

    Time frame: 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

  2. Patient satisfaction score

    Time frame: 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 outcomes

  1. Visual acuity

    Time frame: 6 months

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

  2. Objective refraction

    Time frame: 6 months

    Manifest and objective refraction (spherical equivalent) (Diyoptri)

  3. Defocus curve

    Time frame: 6 months

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

  4. Photic phenomena

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Sakarya Yenikent State Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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