Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population

Sponsor
Alcon Research (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04528069
Collaborator
(none)
58
Enrollment
1
Location
1
Arm
12.5
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the clinical performance of the ACRYSOF® IQ PanOptix® Toric Trifocal intraocular lens (IOL) when implanted in the eye following cataract removal in an Asian population.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: ACRYSOF® IQ PanOptix® Toric Trifocal IOL
  • Procedure: Cataract surgery
N/A

Detailed Description

Both eyes will be implanted with the PanOptix Toric Trifocal IOL. The eye with the highest astigmatism will be implanted first. The second eye will be implanted within 7-14 days of the first eye.

Subjects will attend 10 scheduled visits as follows: 1 screening visit, 1 operative visit and 2 post-operative visits for each eye, and 3 postoperative visits where both eyes will be evaluated.

This study will be conducted in Australia.

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Investigation of the Visual Outcomes and Safety of AcrySof® IQ PanOptix® Toric Trifocal IOLs in an Asian Population
Actual Study Start Date :
Nov 16, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: PanOptix Toric Trifocal IOL

PanOptix Toric Trifocal IOL implanted in the capsular bag in the posterior chamber following cataract surgery and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).

Device: ACRYSOF® IQ PanOptix® Toric Trifocal IOL
Single-piece, ultraviolet and blue-light filtering, foldable, multifocal toric IOL intended to provide vision to aphakic subjects at near, intermediate, and distance and to correct pre-existing corneal astigmatism. This device is approved in Australia.
Other Names:
  • PanOptix Toric Trifocal IOL
  • Models TFNT30, TFNT40, TFNT50, TFNT60
  • Procedure: Cataract surgery
    Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use

    Outcome Measures

    Primary Outcome Measures

    1. Mean monocular residual manifest cylinder [Up to Month 6]

      Mean monocular residual manifest cylinder will be calculated for all IOL models combined

    2. Percentage of IOLs with less than 10 degree rotation [Day 1 postoperative, up to Month 6]

      Rotation is defined as the difference in IOL axis of orientation from Day 1 postoperative

    3. Mean binocular Best Corrected Distance Visual Acuity (BCDVA) [Up to Month 6]

      Visual acuity will be assessed at a distance of 4 meters under well-lit conditions with spectacles or other visual corrective devices in place. Eyes will be assessed together.

    4. Mean binocular Distance Corrected Intermediate Visual Acuity (DCIVA) [Up to Month 6]

      Visual acuity will be assessed at a distance of 60 centimeters under well-lit conditions with spectacles or other visual corrective devices in place. Eyes will be assessed together.

    5. Mean binocular Distance Corrected Near Visual Acuity (DCNVA) [Up to Month 6]

      Visual acuity will be assessed at a distance of 40 centimeters under well-lit conditions with spectacles or other visual corrective devices in place. Eyes will be assessed together.

    6. Rate of Secondary Surgical Interventions (SSIs), by category [Up to Month 6]

      A secondary surgical intervention (SSI) is defined as a surgical procedure occurring after primary implantation of the IOL. The rate of SSIs will be reported categorically, as the rate of SSIs related to optical properties of the IOL, and the rate of all SSIs.

    7. Rate of visual disturbances, by category [Up to Month 6]

      Visual disturbances will be assessed by the subject using the Questionnaire for Visual Disturbances (QUVID) and reported categorically as "severe" and "most bothersome." This outcome measure is pre-specified for subjects with binocular implantation (both eyes).

    8. Rate of adverse events [Up to Month 6]

      An adverse event (AE) is defined as untoward medical occurrence, unintended disease or injury, or untoward clinical sign (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:
    • Planned bilateral cataract removal followed by posterior chamber IOL implantation with PanOptix Toric (TFNT30, TFNT40, TFNT50, or TFNT60);

    • Calculated target residual refractive error within ±0.50 diopter (D) of emmetropia within the commercially available IOL Power Range in both operative eyes;

    • Preoperative regular corneal keratometric astigmatism with predicted residual refractive astigmatism ≤ 0.50 diopter (D) in both operative eyes;

    • Other protocol-defined inclusion criteria may apply.

    Key Exclusion Criteria:
    • Preoperative irregular astigmatism;

    • Clinically significant corneal abnormalities;

    • Glaucoma;

    • History of or current retinal disease; anterior or posterior segment inflammation;

    • Other planned ocular surgical procedures including, but not limited to, limbal relaxing incision (LRI);

    • Other protocol-defined exclusion criteria may apply.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Alcon Investigative SiteCampsieNew South WalesAustralia2194

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Sr. Clinical Trial Lead, CDMA Surgical, Alcon Research, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT04528069
    Other Study ID Numbers:
    • ILX140-P001
    First Posted:
    Aug 27, 2020
    Last Update Posted:
    May 27, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Alcon Research
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 27, 2021