PMCF Study of Preloaded Trifocal IOL

Sponsor
ICARES Medicus, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04884178
Collaborator
AST Products, Inc. (Industry)
30
Enrollment
1
Location
1
Arm
7
Anticipated Duration (Months)
4.3
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
N/A

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:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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

ArmIntervention/Treatment
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

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Chang Gung Memorial Hospital, LinkouTaoyuanTaiwan

    Sponsors and Collaborators

    • ICARES Medicus, Inc.
    • AST Products, Inc.

    Investigators

    • Principal Investigator: Chiun-Ho Hou, Dr., Chang Gung Memorial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ICARES Medicus, Inc.
    ClinicalTrials.gov Identifier:
    NCT04884178
    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:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ICARES Medicus, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 27, 2021