PMCF Study of Preloaded Trifocal IOL

April 18, 2024 updated by: ICARES Medicus, Inc.

Post-Market Clinical Follow-up Study of Preloaded Trifocal IOL Delivery System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taoyuan, Taiwan
        • Chang Gung Memorial Hospital, Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Photopic monocular CDVA, 400 cm
Time Frame: 6 Months post second eye implantation
6 Months post second eye implantation
Photopic monocular CIVA, 60 cm
Time Frame: 6 Months post second eye implantation
6 Months post second eye implantation
Photopic monocular CNVA, 40 cm
Time Frame: 6 Months post second eye implantation
6 Months post second eye implantation
Rates of adverse events vs. ISO 11979-7:2018 SPE rate
Time Frame: 6 Months post second eye implantation
6 Months post second eye implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ICARES Medicus, Inc.

Collaborators

AST Products, Inc.

Investigators

  • Principal Investigator: Yih-Shiou Hwang, Dr., Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2021

Primary Completion (Actual)

April 18, 2022

Study Completion (Actual)

August 22, 2023

Study Registration Dates

First Submitted

May 7, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPRO-000001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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