Clinical trial Recruiting at 1 site Interventional Ages 22 to 85

Comparing five extended-depth-of-focus intraocular lenses and one standard monofocal lens for cataract surgery

Official title: Visual Performance, Patient Satisfaction, and Quality of Vision Outcomes in Presbyopia-Correcting IOLs: A Prospective Clinical Study

Run by Augenklinik Ahaus G + H GmbH & Co. KG · NCT07051720 · Data updated 2026-11-12

This test compares five extended-depth-of-focus intraocular lenses and one standard monofocal lens in adults having cataract surgery in both eyes to see which provides the best distance, intermediate, and near vision and reduces the need for glasses.

More Cataract and IOL Surgery trials

Quick facts

Study typeInterventional
Ages22 Years to 85 Years
SexAll
Enrollment180 (estimated)
SponsorAugenklinik Ahaus G + H GmbH & Co. KG
Academic / other
Locations1 site (Ahaus, North Rhine-Westphalia)
StatusRecruiting
StartedApril 12, 2022
Main results expectedOctober 2025
Study endsJanuary 2026
Registry record updatedJuly 4, 2025
Trial IDNCT07051720 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 22 to 85 requiring bilateral cataract surgery with regular corneal astigmatism under 1.0 diopter and expected postoperative BCDVA of 0.8 decimal or better are the ideal candidates.

Probably not a fit

Patients with prior corneal refractive surgery, irregular astigmatism, significant ocular comorbidities, pupillary abnormalities, or IOL power needs outside +10.0 D to +30.0 D are unlikely to be eligible or to benefit from the lenses tested.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, interventional comparison enrolls adults undergoing bilateral cataract surgery who receive one of six intraocular lens (IOL) models implanted in both eyes. The five enhanced-depth-of-focus (EDOF) lenses (TECNIS Eyhance, AcrySof IQ Vivity, LuxSmart, Rayner EMV, Eyecryl SERT) are compared head-to-head against a standard monofocal lens (CT ASPHINA 409M). Outcomes include uncorrected and best-corrected visual acuity at multiple distances, patient-reported satisfaction, and spectacle dependence. Participants must meet ocular health criteria such as regular corneal astigmatism <1.0 D and be within the available IOL power range.

Why it matters

Potential benefit: If successful, the trial could identify which lens designs give the best range of clear vision and reduce reliance on glasses after cataract surgery.

How similar studies have gone: Previous studies comparing EDOF and monofocal IOLs have generally reported improved intermediate vision and reduced spectacle dependence with EDOF designs, but direct head-to-head comparisons across these specific lenses are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Bilateral implantation of the same intraocular lens (IOL) model
* Expected postoperative best-corrected distance visual acuity (BCDVA) of 0.8 (decimal) or better
* Regular corneal astigmatism less than 1 diopter

Exclusion Criteria:

* Endothelial cell density \< 2,000 cells/mm²
* Required IOL power for emmetropia falls outside the available range of +10.0 D to +30.0 D
* Pupillary abnormalities
* Intraocular inflammation
* Recent ocular trauma or ocular surgery that is unresolved/unstable, or which may impair visual outcomes or increase patient risk
* History of corneal refractive surgery (e.g., LASIK, LASEK, PRK)
* Irregular astigmatism, as well as corneal abnormalities or opacities
* Conditions associated with an increased risk of zonular rupture, including capsular or zonular anomalies that may lead to IOL decentration or tilt, such as pseudoexfoliation syndrome, trauma, Marfan syndrome, among others
* Systemic or ocular diseases, or medications, that may impair vision, increase surgical risk, or confound study outcomes
* Clinically significant dry eye disease affecting visual function
* Anticipated need for retinal laser treatment or any other ocular surgical intervention during the study period
* Pregnancy, planned pregnancy, breastfeeding, or any condition associated with hormonal fluctuations that may induce refractive changes
* Continuous contact lens wear within the past 4 weeks
* Inability to understand and/or complete study questionnaires
* Advanced glaucoma with visual field defects
* Age-related macular degeneration (exudative or geographic form)

Where it's running

  • Augenklinik Ahaus
    Ahaus, North Rhine-Westphalia, Germany
    Recruiting

Study contacts

  • Principal investigator: dr. med. (Univ. Bud.) Matthias Gerl, MD — Augenklinik Ahaus
  • Study coordinator: dr. med. (Univ. Bud.) Matthias Gerl, MD
  • Email: m.gerl@augenklinik.de
  • Phone: +49 (2561) 9555-301

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.