Clinical trial NCT04884178: PMCF Study of Preloaded Trifocal IOL
Official title: Post-Market Clinical Follow-up Study of Preloaded Trifocal IOL Delivery System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Cataract
Trifocal
IOL
Intraocular lens
Preloaded
Aphakic
Spectacle independence
Asqelio
aspicio
AST Products
ICARES
Lead sponsor: ICARES Medicus, Inc.
Sponsor class: INDUSTRY
Collaborators: name: AST Products, Inc.
First posted: 2021-05-12
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Photopic monocular CDVA, 400 cm
timeFrame: 6 Months post second eye implantation
measure: Photopic monocular CIVA, 60 cm
timeFrame: 6 Months post second eye implantation
measure: Photopic monocular CNVA, 40 cm
timeFrame: 6 Months post second eye implantation
measure: Rates of adverse events vs. ISO 11979-7:2018 SPE rate
timeFrame: 6 Months post second eye implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yih-Shiou Hwang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: