CompletedNot Applicable

Safety and Efficacy of the Bi-Aspheric Monofocal IOL

Taiwan30 participantsStarted 2024-03-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subjects 18 years of age or older who have been implanted with aspicio™ monofocal intraocular lens in at least 1 eye
✓. Willingness to cooperate with and complete all post-operative visits
✓. Ability to comprehend and sign an informed consent

Exclusion criteria

✕. 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).
✕. Previous ocular surgery (including YAG-laser) or trauma
✕. Clinically significant irregular astigmatism
✕. Concomitant severe eye disease
✕. Pregnant or lactating
✕. Any other ocular or systemic condition which, in the opinion of the investigator, should exclude the subject from the study
✕. Concurrent participation in another drug or device investigation
✕. May be expected to require other ocular surgery during the study

What they're measuring

CDVA

Timeframe: 3 months after implantation

Defocus curve

Timeframe: 3 months after implantation

Trial details

NCT IDNCT06380478

SponsorICARES Medicus, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-08-12

View on ClinicalTrials.gov More Cataract trials