PMCF Study of Preloaded Trifocal IOL

Launched by ICARES MEDICUS, INC. · May 7, 2021

Keywords

ClinConnect Summary

This study is a single-arm unmasked clinical evaluation study of safety, effectiveness and patient satisfactions of the Trifocal Intraocular Lens after successful bilateral cataract surgery. Subjects will be assessed pre-operative, operative date and at 1-2 days, 1-2 weeks, 1-2 months, 3-4 months and 6 months post-operative. Clinical evaluations will include probability of adverse events, patient satisfaction questionnaire, as well as measurements of monocular and bilateral far, intermediate and near visual acuity as a result of Trifocal Lens performance, etc.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Bilateral cataracts: Adults, 20 years of age or older at the time of informed consent, of either gender, diagnosed with bilateral cataracts
• • Desire for high post-operative spectacle independence
• • Willingness to cooperate with and complete all post-operative visits
• • Calculated lens power within +5.0 D and +34.0 D
• • Planned cataract removal by phacoemulsification
• • Clear intraocular media other that cataracts in both eyes
• • Potential post-operative visual acuity of 20/25 or better
• • Ability to comprehend and sign an informed consent
• • Signed informed consent
• Exclusion Criteria:
• • More than 1.0 D of pre-operative corneal astigmatism
• • Expected post-operative astigmatism of more than 0.75 D
• • Mature/dense cataract which makes the pre-operative fundus examination difficult
• • Previous ocular surgery or trauma
• • Clinically significant irregular astigmatism
• • Choroidal hemorrhage
• • Microphthalmos
• • Severe corneal dystrophy
• • Medically controlled or uncontrolled glaucoma
• • Clinically significant macular/RPE changes
• • Concomitant severe eye disease
• • Severe optic nerve atrophy
• • Diabetic retinopathy, proliferative or macular edema
• • Amblyopia
• • Extremely shallow anterior chamber
• • Chronic sever uveitis
• • Pregnant or lactating
• • Previous retinal detachment
• • Previous corneal transplant
• • Concurrent participation in another drug or device investigation
• • May be expected to require other ocular surgery during the study