Extended Depth of Focus (EDF) Intraocular Lens (IOL) Versus Monofocal Intracoular Lens (IOL)

Last updated: March 11, 2026
Sponsor: Carl Zeiss Meditec AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Eye Disease

Vision Loss

Treatment

EDF

Monofocal IOL

Clinical Study ID

NCT07092020
AT LARA 829MP BER-401-24
  • Ages > 18
  • All Genders

Study Summary

Extended depth of focus (EDF) intraocular lens (IOL) versus Monofocal intraocular lens (IOL)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients of any gender, aged 18 years or older

  2. Patient with clinically significant bilateral age-related cataracts planned forphacoemulsification cataract extraction and eligible for implantation of a posteriorchamber intraocular lens as determined by investigator's medical judgement

  3. Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D)

  4. Calculated lens power within the available range

  5. Clear intraocular media other than cataract

  6. Patient is willing and capable of providing informed consent

  7. Patient is willing and capable of complying with visits and procedures as defined bythis protocol

Exclusion

Exclusion Criteria:

  1. Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5decimal)

  2. Endothelial cell count of less than 2000/mm2

  3. Acute, chronic, or uncontrolled systemic disease that could increase the operativerisk or confound the outcome including but not limited to poorly controlled diabetesmellitus, active cancer treatment, mental illness, dementia, immunocompromised,connective tissue disease, clinically significant atopic disease, etc.

  4. Ocular condition that may predispose patient to future complications, perinvestigator's medical judgement, including but not limited to severe dry eye,anterior segment pathology, uncontrolled glaucoma, that would result in a visualacuity of 0.2 logMAR or worse during the study

  5. Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity or oedema as perInvestigator's medical judgement; conditions including but not limited tokerato-uveitis, keratopathy, keratectasia

  6. Previous intraocular or corneal/refractive surgery that might confound the outcomeof the investigation or increase the risk to the patient (including cornealtransplants, removal of pterygium, and LASIK, LASEK, PRK, RK limbal relaxingincision etc.)

  7. Any clinically significant condition that could affect IOL stability (e.g. zonulardialysis, evident zonular weakness or dehiscence, etc.)

  8. Patients with diagnosed degenerative visual disorders (e.g. macular degeneration orother retinal disorders, optic nerve atrophy etc.) or any other pathologies of theeye that are predicted to result in a visual acuity of 0.2 logMAR or worse duringthe study

  9. Current systemic or ocular pharmacotherapy that effects patients' vision withsignificant ocular side effects or any medications that could confound the outcomeor increase subject risk

  10. Clinically significant gonioscopic abnormalities

  11. Amblyopia, strabismus, single eye status

  12. Rubella, congenital, traumatic or complicated cataracts

  13. History of or current anterior or posterior segment inflammation, including but notlimited to iritis or uveitis

  14. Microphthalmos or macrophthalmos

  15. Pupil abnormalities (e.g. aniridia, abnormal shaped pupils, nonreactive pupils)

  16. Pseudoexfoliation

  17. Keratoconus or irregular astigmatism

  18. Inability to measure keratometry or biometry (including but not limited to cataractdensity, etc.)

  19. Pathologic miosis

  20. Pregnant, plan to become pregnant, lactating during the course of the investigation,or another condition with associated fluctuation of hormones that could lead torefractive changes

  21. Patients unable to meet the limitations of the protocol or likely of non-cooperationduring the trial

  22. Patients whose freedom is impaired by administrative or legal order

  23. Concurrent participation in another clinical investigation in the last 30 days.

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: EDF
Phase:
Study Start date:
October 01, 2025
Estimated Completion Date:
October 31, 2027

Study Description

Extended depth of Focus intraocular lens versus a monofocal intraocular lens

Connect with a study center

  • Eye Hospital Zora

    Sofia,
    Bulgaria

    Active - Recruiting

  • Specialized Ophthalmological Hospital for Active Treatment

    Sofia,
    Bulgaria

    Active - Recruiting

  • Medical Center "Vereya"

    Stara Zagora,
    Bulgaria

    Active - Recruiting

  • Nemocnice Havlíčkův

    Havlíčkův Brod,
    Czechia

    Active - Recruiting

  • OFTEX ocni

    Pardubice,
    Czechia

    Active - Recruiting

  • Oční Centrum

    Prague,
    Czechia

    Active - Recruiting

  • Oculus Eye Clinic

    Bucharest,
    Romania

    Site Not Available

  • Oculus Eye Clinic

    Bucuresti,
    Romania

    Site Not Available

  • Ofta Total Clinic

    Sibiu,
    Romania

    Site Not Available

  • Medoptic Clinic

    Suceava,
    Romania

    Site Not Available

  • Oftalvist

    Alicante,
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid,
    Spain

    Active - Recruiting

  • OMIQ Hospital Universitari

    Sant Cugat del Vallès,
    Spain

    Site Not Available

  • University Hopital Complex of Santiago de Compostela

    Santiago de Compostela,
    Spain

    Site Not Available

  • Oftalvist

    Valencia,
    Spain

    Active - Recruiting

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