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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04528069
Registration number
NCT04528069
Ethics application status
Date submitted
24/08/2020
Date registered
27/08/2020
Date last updated
30/12/2022
Titles & IDs
Public title
Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population
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Scientific title
Clinical Investigation of the Visual Outcomes and Safety of AcrySof® IQ PanOptix® Toric Trifocal IOLs in an Asian Population
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Secondary ID [1]
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ILX140-P001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aphakia
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Corneal Astigmatism
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - ACRYSOF® IQ PanOptix® Toric Trifocal IOL
Treatment: Surgery - Cataract surgery
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).
Treatment: Devices: 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.
Treatment: Surgery: Cataract surgery
Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean Monocular Residual Manifest Cylinder for All Operative Eyes for All IOL Models Combined
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Assessment method [1]
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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.
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Timepoint [1]
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Month 3 postoperative, Month 6 postoperative
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Primary outcome [2]
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Percentage of Eyes With IOL Rotation Less Than 10 Degrees
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Assessment method [2]
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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.
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Timepoint [2]
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Month 3 postoperative, Month 6 postoperative
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Primary outcome [3]
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Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)
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Assessment method [3]
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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.
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Timepoint [3]
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Month 3 postoperative, Month 6 postoperative
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Primary outcome [4]
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Mean Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
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Assessment method [4]
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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.
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Timepoint [4]
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Month 3 postoperative, Month 6 postoperative
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Primary outcome [5]
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Mean Binocular Distance Corrected Near Visual Acuity (DCNVA)
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Assessment method [5]
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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.
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Timepoint [5]
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Month 3 postoperative, Month 6 postoperative
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Primary outcome [6]
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Percentage of Eyes With Secondary Surgical Interventions (SSIs), by Category
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Assessment method [6]
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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.
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Timepoint [6]
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Up to Month 6 postoperative
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Primary outcome [7]
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Percentage of Subjects With a Severe Visual Disturbance
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Assessment method [7]
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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.
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Timepoint [7]
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Preoperative, Month 3 postoperative, Month 6 postoperative
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Primary outcome [8]
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Percentage of Subjects With a Most Bothersome Visual Disturbance (QUVID)
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Assessment method [8]
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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.
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Timepoint [8]
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Preoperative, Month 3 postoperative, Month 6 postoperative
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Primary outcome [9]
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Percentage of Subjects With Ocular Serious Adverse Events Including Serious Adverse Device Effects
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Assessment method [9]
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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.
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Timepoint [9]
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Up to Month 6 postoperative
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Primary outcome [10]
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Percentage of Subjects With Nonocular Serious Adverse Events Including Serious Adverse Device Effects
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Assessment method [10]
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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.
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Timepoint [10]
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Up to Month 6 postoperative
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Eligibility
Key inclusion criteria
Key
- 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.
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Minimum age
20
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)/Astigmatic Keratotomy and laser-assisted in situ
keratomileusis (LASIK);
- Other protocol-defined exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/11/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/12/2021
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Sample size
Target
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Accrual to date
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Final
58
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Alcon Investigator 8117 - Campsie
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Recruitment hospital [2]
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Alcon Investigator 7678 - Sydney
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Recruitment hospital [3]
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Alcon Investigator 7813 - Footscray
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Recruitment hospital [4]
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Alcon Investigator 8122 - Saint Albans
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Recruitment postcode(s) [1]
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2194 - Campsie
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Recruitment postcode(s) [2]
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2150 - Sydney
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Recruitment postcode(s) [3]
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3011 - Footscray
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Recruitment postcode(s) [4]
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3021 - Saint Albans
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Alcon Research
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04528069
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sr. Clinical Trial Lead, CDMA Surgical
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Address
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Alcon Research, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04528069
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