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CompletedNCT07548294Updated Apr 23, 2026

EDOF vs Enhanced vs Monofocal IOLs After Bilateral Cataract Surgery

An observational study in Age-related Cataract, sponsored by Sakarya Yenikent State Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Sakarya Yenikent State Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
197
Ages
45 Years and older
Sex
All
01

Study 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.

Read the 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).

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Conditions studied

  • Age-related Cataract

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Keywords

  • CATARACT SURGERY
  • DEFOCUS CURVE
  • Extended depth-of-focus
  • Enhanced monofocal
  • Visual acuity
  • Patient satisfaction
  • Intraocular lens
03

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
197 participants (actual)
Patient registry
No

Groups and cohorts

  • Monofocal IOL

    Tecnis ZCB00 (Johnson \& Johnson Vision)

  • Enhanced monofocal IOL

    Tecnis Eyhance ICB00 (Johnson \& Johnson Vision)

  • EDOF IOL

    Asqelio EDOF ETLIO130C (AST Products)

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What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. Visual acuity

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

    Time frame: 6 months

  2. Objective refraction

    Manifest and objective refraction (spherical equivalent) (Diyoptri)

    Time frame: 6 months

  3. Defocus curve

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

    Time frame: 6 months

  4. Photic phenomena

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

    Time frame: 6 months

06

Study locations

1 site
  • Sakarya Yenikent State Hospital
    Sakarya, Adapazarı 54140, Turkey (Türkiye)
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 6, 2024
  • Informed consent form · Feb 6, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT07548294
Lead sponsor
Sakarya Yenikent State Hospital
Responsible party
Ali Altan Ertan Boz (M.D. Head of Ophthalmology Department, Sakarya Yenikent State Hospital) — Principal investigator
First posted
Apr 23, 2026
Start date
Jan 5, 2022
Primary completion
Feb 25, 2024
Completion
Jan 20, 2025
Last update
Apr 23, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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