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Recruiting NCT06380478

Safety and Efficacy of the Bi-Aspheric Monofocal IOL

Trial Parameters

Condition Cataract
Sponsor ICARES Medicus, Inc.
Study Type OBSERVATIONAL
Phase N/A
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-03-05
Completion 2025-12-20
Interventions
aspicio Monofocal IOL

Brief Summary

This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a follow-up visit at least 3 months after the surgery to undergo a routine basic ophthalmological examination.

Eligibility Criteria

Inclusion Criteria: 1. Subjects 18 years of age or older who have been implanted with aspicio™ monofocal intraocular lens in at least 1 eye 2. Willingness to cooperate with and complete all post-operative visits 3. Ability to comprehend and sign an informed consent Exclusion Criteria: 1. Any pathology that could reduce Visual Acuity (VA) (including amblyopia, severe corneal dystrophy, diabetic retinopathy, extremely narrow anterior chamber depth, microphthalmos, clinically significant macular/RPE changes, retinal detachment, corneal transplant, chronic sever uveitis, choroidal hemorrhage, recurrent severe inflammation of the anterior or posterior segment of unknown etiology, iris neovascularization, medically controlled or uncontrolled glaucoma, clinically significant macular degeneration, or diagnosis of pseudoexfoliation). 2. Previous ocular surgery (including YAG-laser) or trauma 3. Clinically significant irregular astigmatism 4. Concomitant severe eye disease 5. Pregnant or lactati

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