PMCF Study of Preloaded Trifocal IOL
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 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 |
Device: Trifocal Preloaded IOL Delivery System
UV and blue-light filtering foldable trifocal IOL with a +2.2 diopter (D) addition power of intermediate visual acuity and a +3.3 D addition power of near visual acuity. This device is approved in Taiwan.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Bilateral cataracts: Adults, 20 years of age or older at the time of informed consent, of either gender, diagnosed with bilateral cataracts
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Desire for high post-operative spectacle independence
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Willingness to cooperate with and complete all post-operative visits
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Calculated lens power within +5.0 D and +34.0 D
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Planned cataract removal by phacoemulsification
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Clear intraocular media other that cataracts in both eyes
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Potential post-operative visual acuity of 20/25 or better
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Ability to comprehend and sign an informed consent
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Signed informed consent
Exclusion Criteria:
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More than 1.0 D of pre-operative corneal astigmatism
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Expected post-operative astigmatism of more than 0.75 D
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Mature/dense cataract which makes the pre-operative fundus examination difficult
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Previous ocular surgery or trauma
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Clinically significant irregular astigmatism
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Choroidal hemorrhage
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Microphthalmos
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Severe corneal dystrophy
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Medically controlled or uncontrolled glaucoma
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Clinically significant macular/RPE changes
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Concomitant severe eye disease
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Severe optic nerve atrophy
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Diabetic retinopathy, proliferative or macular edema
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Amblyopia
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Extremely shallow anterior chamber
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Chronic sever uveitis
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Pregnant or lactating
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Previous retinal detachment
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Previous corneal transplant
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Concurrent participation in another drug or device investigation
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May be expected to require other ocular surgery during the study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Chang Gung Memorial Hospital, Linkou | Taoyuan | Taiwan |
Sponsors and Collaborators
- ICARES Medicus, Inc.
- AST Products, Inc.
Investigators
- Principal Investigator: Chiun-Ho Hou, Dr., Chang Gung Memorial Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CPRO-000001