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PMCF Study of Preloaded Trifocal IOL

Primary Purpose

Cataract

Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Trifocal Preloaded IOL Delivery System
Sponsored by
ICARES Medicus, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract, Trifocal, IOL, Intraocular lens, Preloaded, Aphakic, Spectacle independence, Asqelio, aspicio, AST Products, ICARES

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chang Gung Memorial Hospital, Linkou

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trifocal Preloaded IOL Delivery System

Arm Description

Bilateral trifocal IOLs implanted through preloaded IOL Delivery System in the capsular bag in the posterior chamber of the eye during cataract surgery

Outcomes

Primary Outcome Measures

Photopic monocular CDVA, 400 cm
Photopic monocular CIVA, 60 cm
Photopic monocular CNVA, 40 cm
Rates of adverse events vs. ISO 11979-7:2018 SPE rate

Secondary Outcome Measures

Full Information

First Posted
May 7, 2021
Last Updated
May 21, 2023
Sponsor
ICARES Medicus, Inc.
Collaborators
AST Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04884178
Brief Title
PMCF Study of Preloaded Trifocal IOL
Official Title
Post-Market Clinical Follow-up Study of Preloaded Trifocal IOL Delivery System
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
April 18, 2022 (Actual)
Study Completion Date
August 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ICARES Medicus, Inc.
Collaborators
AST Products, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Trifocal, IOL, Intraocular lens, Preloaded, Aphakic, Spectacle independence, Asqelio, aspicio, AST Products, ICARES

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trifocal Preloaded IOL Delivery System
Arm Type
Experimental
Arm Description
Bilateral trifocal IOLs implanted through preloaded IOL Delivery System in the capsular bag in the posterior chamber of the eye during cataract surgery
Intervention Type
Device
Intervention Name(s)
Trifocal Preloaded IOL Delivery System
Other Intervention Name(s)
Asqelio Trifocal, TFPIO130Y, TFLIO130, aspicio Trifocal, PTF60Y, TF60
Intervention Description
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 Measure Information:
Title
Photopic monocular CDVA, 400 cm
Time Frame
6 Months post second eye implantation
Title
Photopic monocular CIVA, 60 cm
Time Frame
6 Months post second eye implantation
Title
Photopic monocular CNVA, 40 cm
Time Frame
6 Months post second eye implantation
Title
Rates of adverse events vs. ISO 11979-7:2018 SPE rate
Time Frame
6 Months post second eye implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yih-Shiou Hwang, Dr.
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

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PMCF Study of Preloaded Trifocal IOL

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