Cataract
Conditions
Keywords
Cataract, Trifocal, IOL, Intraocular lens, Preloaded, Aphakic, Spectacle independence, Asqelio, aspicio, AST Products, ICARES
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.
Interventions
DEVICETrifocal 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.
Sponsors
AST Products, Inc.
ICARES Medicus, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Taiwan
Outcome results
None listed