Status:
ACTIVE_NOT_RECRUITING
Photopic and Mesopic Multifocal IOL Performance
Lead Sponsor:
IROC AG
Collaborating Sponsors:
AMO Ireland
Conditions:
Cataract
Presbyopia Correction
Eligibility:
All Genders
45+ years
Brief Summary
Modern cataract surgery has become a refractive procedure. Both, multifocal lens implantation and pseudophakic monovision with monofocal IOLs are effective means to address presbyopia correction after...
Eligibility Criteria
Inclusion
- Male and female subjects age 45 years of age and older
- Able to provide written informed consent and follow study instructions in English or German.
- Desire for spectacle independence
- Agreement on clinical decision for planned crystalline lens exchange with multifocal IOL implantation (Standardized femtosecond-laser capsulotomy (diameter 5.3mm))
- Willing and able to return for scheduled follow-up examinations;
Exclusion
- Prior ophthalmic surgery or trauma
- Zonular-defects, unstable bag
- Macular pathologies
- Excessive irregular astigmatism
- 6\. Pregnancy/lactation 7. Predicted Visual acuity of less than 0.8 decimal 8. Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;
Key Trial Info
Start Date :
January 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06978556
Start Date
January 1 2023
End Date
June 1 2025
Last Update
May 21 2025
Active Locations (1)
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1
IROC
Zurich, Canton of Zurich, Switzerland, 8002