PMCF Study of Preloaded Trifocal IOL
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|
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.
Arms and Interventions
|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.
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]
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
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
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
Contacts and Locations
|1||Chang Gung Memorial Hospital, Linkou||Taoyuan||Taiwan|
Sponsors and Collaborators
- ICARES Medicus, Inc.
- AST Products, Inc.
- Principal Investigator: Chiun-Ho Hou, Dr., Chang Gung Memorial Hospital
Study Documents (Full-Text)None provided.