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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1
Augenklinik Ahaus
Ahaus, North Rhine-Westphalia, Germany, 48683