Status:
COMPLETED
PMCF Study of Preloaded Trifocal IOL
Lead Sponsor:
ICARES Medicus, Inc.
Collaborating Sponsors:
AST Products, Inc.
Conditions:
Cataract
Eligibility:
All Genders
20+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04884178
Start Date
August 23 2021
End Date
August 22 2023
Last Update
April 19 2024
Active Locations (1)
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1
Chang Gung Memorial Hospital, Linkou
Taoyuan District, Taiwan