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

NCT04528069 | Completed Results FDA Device

• 1 other identifier: ILX140-P001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 4

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.

Conditions

Aphakia; Corneal Astigmatism

Keywords

Intraocular lens; Cataract

Outcome Measures

Primary Outcomes (10)

• Mean Monocular Residual Manifest Cylinder for All Operative Eyes for All IOL Models Combined

  Manifest cylinder is the amount of added correction needed to compensate for any astigmatism that may be present. A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Residual manifest cylinder was measured in diopters and reported in plus cylinder form, with a smaller number indicating a lesser amount of added correction. Eyes were assessed individually and combined for the analysis. No formal statistical hypothesis testing was prespecified for this outcome measure.

  Month 3 postoperative, Month 6 postoperative

• Percentage of Eyes With IOL Rotation Less Than 10 Degrees

  IOL rotation was defined as the difference in IOL axis of orientation from Day 1 postoperative. IOL rotation was assessed by the investigator using a slit lamp and was recorded in degrees, with a smaller number indicating less rotation. Eyes were assessed individually and combined for the analysis. No formal statistical hypothesis testing was prespecified for this outcome measure.

  Month 3 postoperative, Month 6 postoperative

• Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)

  Visual acuity (VA) was assessed at a distance of 4 meters with refractive correction in place using a visual acuity chart. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. Eyes were assessed binocularly (eyes together). A lower value denotes better visual acuity. No formal statistical hypothesis testing was prespecified for this outcome measure.

  Month 3 postoperative, Month 6 postoperative

• Mean Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)

  Visual acuity (VA) was assessed at a distance of 60 meters with distance correction (plus or minus power) in place. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. Eyes were assessed binocularly (eyes together). A lower value denotes better visual acuity. No formal statistical hypothesis testing was prespecified for this outcome measure.

  Month 3 postoperative, Month 6 postoperative

• Mean Binocular Distance Corrected Near Visual Acuity (DCNVA)

  Visual acuity (VA) was assessed at a distance of 40 centimeters with distance correction (plus or minus power) in place using a visual acuity chart. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. Eyes were assessed binocularly (eyes together). A lower value denotes better visual acuity. No formal statistical hypothesis testing was prespecified for this outcome measure.

  Month 3 postoperative, Month 6 postoperative

• Percentage of Eyes With Secondary Surgical Interventions (SSIs), by Category

  A secondary surgical intervention (SSI) was defined as a surgical procedure occurring after primary implantation of the IOL. SSIs are reported categorically as SSIs related to the IOL and due to optical properties, SSIs related to the IOL and not due to optical properties, and SSIs unrelated to the IOL.

  Up to Month 6 postoperative

• Percentage of Subjects With a Severe Visual Disturbance

  The Questionnaire for Visual Disturbances (QUVID) is a patient-reported outcomes questionnaire that collects responses from the subject about 7 vision-related experiences. For each experience, the subject was asked if he/she had experienced it during the past 7 days. Subjects responding "Yes" were then asked to rate how severe their worst experience was during the past 7 days. Subjects responded on a 5-point scale: 0=None; 1=A little; 2=Mild; 3=Moderate; 4=Severe. Subjects responding "No" were automatically imputed as reporting, "0=None." Percentage was calculated as number of subjects with response in specified category divided by number of subjects with data regardless of response, times 100. No formal statistical hypothesis testing was prespecified for this outcome measure.

  Preoperative, Month 3 postoperative, Month 6 postoperative

• Percentage of Subjects With a Most Bothersome Visual Disturbance (QUVID)

  QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about 7 vision-related experiences. For each experience, the subject was asked if he/she had experienced it during the past 7 days. Subjects responding "Yes" were then asked to rate how severe their worst experience was with the vision-related experience in the past 7 days. Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all. Percentage was calculated as number of subjects with response in specified category divided by number of subjects with data regardless of response, times 100. No formal statistical hypothesis testing was prespecified for this outcome measure.

  Preoperative, Month 3 postoperative, Month 6 postoperative

• Percentage of Subjects With Ocular Serious Adverse Events Including Serious Adverse Device Effects

  An adverse event (AE) was 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). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No formal statistical hypothesis testing was prespecified for this outcome measure.

  Up to Month 6 postoperative

• Percentage of Subjects With Nonocular Serious Adverse Events Including Serious Adverse Device Effects

  An adverse event (AE) was 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). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No formal statistical hypothesis testing was prespecified for this outcome measure.

  Up to Month 6 postoperative

Study Arms (1)

PanOptix Toric Trifocal IOL

EXPERIMENTAL

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; Procedure: Cataract surgery

Interventions

ACRYSOF® IQ PanOptix® Toric Trifocal IOL DEVICE

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.

Also known as: PanOptix Toric Trifocal IOL, Models TFNT30, TFNT40, TFNT50, TFNT60

PanOptix Toric Trifocal IOL

Cataract surgery PROCEDURE

Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use

PanOptix Toric Trifocal IOL

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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)/Astigmatic Keratotomy and laser-assisted in situ keratomileusis (LASIK);

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (4)

Alcon Investigator 8117

Campsie, New South Wales, 2194, Australia

Location

Alcon Investigator 7678

Sydney, New South Wales, 2150, Australia

Location

Alcon Investigator 7813

Footscray, Victoria, 3011, Australia

Location

Alcon Investigator 8122

Saint Albans, Victoria, 3021, Australia

Location

MeSH Terms

Conditions

Aphakia; Astigmatism; Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Director of Clinical Projects, Surgical
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr. Clinical Trial Lead, CDMA Surgical

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 27, 2020
• Study Start: November 16, 2020
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: December 30, 2022
• Results First Posted: December 30, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)