NL-OMON41971CompletedPhase 3
Prospective multicenter clinical trial with the PRECIZION Presbyopic multifocal intraocular lens - PRECIZION Presbyopic clinical trial
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- OPHTEC BV
- Enrollment
- 10
Study Overview
Brief Summary
Trial is onging in other countries
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •* Patient must be 45 years of age or older
- •* Presbyopic
- •* Cataract patient or Clear Lens Extraction (CLE) candidate
- •* Patient wishes to be spectacle independent for near and far vision
- •* Patient lifestyle and outlook fit with multifocal IOL implantation
- •* Qualifies for bilateral implantation
- •* Patients must have a calculated IOL power within the available diopter range
- •* Expected best corrected visual acuity of 0.5 or better after IOL implantation
- •* No secondary surgical procedure planned during the course of the study
- •* Availability, willingness and sufficient cognitive awareness and physical ability to comply with examination procedures throughout the entire duration of the study
- •* Patients must provide written informed consent
- •* The predicted keratometric postoperative astigmatism (calculated with respect to the surgical induced astigmatism) must be <1.0 D.
Exclusion Criteria
- •* Ocular disease other than cataract that may predispose for future complications or might confound the outcome of the investigation (e.g anterior segment pathology, glaucoma, corneal dystrophy, ocular inflammation, pseudoexfoliation syndrome, retinal disorders)
- •* Acute or chronic disease or illness or use of medication that could confound the outcome of the study or increase the risk to the subject
- •* Endothelial cell count <1500 cells/mm2
- •* Amblyopia
- •* Congenital eye abnormalities
- •* Previous ocular surgery that might confound the outcome of the investigation or increase risk to patient.
- •* Concurrent participation or participation during the last 30 days in any other clinical trial
- •* Patient must not be pregnant or has another condition with associated fluctuation of hormones that could lead to refractive changes
Investigators
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