Status:

RECRUITING

Head-to-Head Comparison of Five Enhanced Depth of Focus IOLs and One Monofocal IOL

Lead Sponsor:

Augenklinik Ahaus G + H GmbH & Co. KG

Conditions:

Cataract and IOL Surgery

IOL Implantation

Eligibility:

All Genders

22-85 years

Phase:

NA

Brief Summary

Study Goal The goal of this clinical trial is to compare how well four different types of artificial lenses (called intraocular lenses or IOLs) help people see after cataract surgery. The main questi...

Detailed Description

Study Rationale and Clinical Significance The increasing demand for spectacle independence following cataract surgery has driven the development of advanced intraocular lens (IOL) technologies that ex...

Eligibility 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)

Key Trial Info

Start Date :

April 12 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2026

Estimated Enrollment :

180 Patients enrolled

Trial Details

Trial ID

NCT07051720

Start Date

April 12 2022

End Date

January 1 2026

Last Update

July 4 2025

Active Locations (1)

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Augenklinik Ahaus

Ahaus, North Rhine-Westphalia, Germany, 48683