PMCF Study of Preloaded Trifocal IOL

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: Trifocal Preloaded IOL Delivery System

• Registration Number: NCT04884178
• Lead Sponsor: ICARES Medicus, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-05-07
• Study First Submitted QC: 2021-05-07
• Study First Posted: 2021-05-12
• Study Start: 2021-08-23
• Primary Completion: 2022-04-18
• Study Completion: 2023-08-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Photopic monocular CDVA, 400 cm	6 Months post second eye implantation
Photopic monocular CIVA, 60 cm	6 Months post second eye implantation
Photopic monocular CNVA, 40 cm	6 Months post second eye implantation
Rates of adverse events vs. ISO 11979-7:2018 SPE rate	6 Months post second eye implantation

Trial Locations

Locations (1)

Chang Gung Memorial Hospital, Linkou; 🇨🇳 Taoyuan, Taiwan