PMCF Study of Preloaded Trifocal IOL

ICARES Medicus, Inc. (Industry)
Overall Status
Recruiting ID
AST Products, Inc. (Industry)
Anticipated Duration (Months)
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • Device: Trifocal Preloaded IOL Delivery System

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

Study Type:
Anticipated Enrollment :
30 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Post-Market Clinical Follow-up Study of Preloaded Trifocal IOL Delivery System
Actual Study Start Date :
Aug 23, 2021
Anticipated Primary Completion Date :
Mar 24, 2022
Anticipated Study Completion Date :
Mar 24, 2022

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.
Other Names:
  • Asqelio Trifocal
  • TFPIO130Y
  • TFLIO130
  • aspicio Trifocal
  • PTF60Y
  • TF60
  • Outcome Measures

    Primary Outcome Measures

    1. Photopic monocular CDVA, 400 cm [6 Months post second eye implantation]

    2. Photopic monocular CIVA, 60 cm [6 Months post second eye implantation]

    3. Photopic monocular CNVA, 40 cm [6 Months post second eye implantation]

    4. Rates of adverse events vs. ISO 11979-7:2018 SPE rate [6 Months post second eye implantation]

    Eligibility Criteria


    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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

    Contacts and Locations


    SiteCityStateCountryPostal Code
    1Chang Gung Memorial Hospital, LinkouTaoyuanTaiwan

    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.

    More Information


    None provided.
    Responsible Party:
    ICARES Medicus, Inc. Identifier:
    Other Study ID Numbers:
    • CPRO-000001
    First Posted:
    May 12, 2021
    Last Update Posted:
    Aug 27, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by ICARES Medicus, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 27, 2021