PMCF Study of Preloaded Trifocal IOL
- Conditions
- Cataract
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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
- 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
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chang Gung Memorial Hospital, Linkou
🇨🇳Taoyuan, Taiwan
Chang Gung Memorial Hospital, Linkou🇨🇳Taoyuan, Taiwan