Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04528069
Recruitment Status : Completed
First Posted : August 27, 2020
Last Update Posted : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 disease Intervention/treatment Phase
Aphakia Corneal Astigmatism Device: ACRYSOF® IQ PanOptix® Toric Trifocal IOL Procedure: Cataract surgery Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : November 16, 2020
Actual Primary Completion Date : December 17, 2021
Actual Study Completion Date : December 17, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Mean monocular residual manifest cylinder [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528069


Locations
Layout table for location information
Australia, New South Wales
Alcon Investigative Site
Campsie, New South Wales, Australia, 2194
Sponsors and Collaborators
Alcon Research
Investigators
Layout table for investigator information
Study Director: Sr. Clinical Trial Lead, CDMA Surgical Alcon Research, LLC
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT04528069    
Other Study ID Numbers: ILX140-P001
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Intraocular lens
Cataract
Additional relevant MeSH terms:
Layout table for MeSH terms
Astigmatism
Aphakia
Refractive Errors
Eye Diseases
Lens Diseases