PMCF Study of Preloaded Trifocal IOL

ICARES Medicus

Status: Completed

Conditions: Cataract

Treatments: Device: Trifocal Preloaded IOL Delivery System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04884178

CPRO-000001

Details and patient eligibility

About

This is a study to evaluate the safety, effectiveness and patient satisfaction of the Trifocal Intraocular Lens after implanted to replace the natural lens following cataract removal.

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Trifocal Preloaded IOL Delivery System

Experimental group

Description:

Bilateral trifocal IOLs implanted through preloaded IOL Delivery System in the capsular bag in the posterior chamber of the eye during cataract surgery

Treatment:

Device: Trifocal Preloaded IOL Delivery System