- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04528069
Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population
Clinical Investigation of the Visual Outcomes and Safety of AcrySof® IQ PanOptix® Toric Trifocal IOLs in an Asian Population
Study Overview
Status
Conditions
Intervention / Treatment
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 a total of 10 scheduled visits as follows: 1 screening visit, 1 operative visit for each eye, 2 post-operative visits for each eye, and 3 postoperative visits where both eyes will be evaluated. The duration of participation for each subject will be approximately 8 months.
This study will be conducted in Australia.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New South Wales
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Campsie, New South Wales, Australia, 2194
- Alcon Investigator 8117
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Sydney, New South Wales, Australia, 2150
- Alcon Investigator 7678
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Victoria
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Footscray, Victoria, Australia, 3011
- Alcon Investigator 7813
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Saint Albans, Victoria, Australia, 3021
- Alcon Investigator 8122
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)/Astigmatic Keratotomy and laser-assisted in situ keratomileusis (LASIK);
- Other protocol-defined exclusion criteria may apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
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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:
Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Monocular Residual Manifest Cylinder for All Operative Eyes for All IOL Models Combined
Time Frame: Month 3 postoperative, Month 6 postoperative
|
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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Month 3 postoperative, Month 6 postoperative
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Percentage of Eyes With IOL Rotation Less Than 10 Degrees
Time Frame: Month 3 postoperative, Month 6 postoperative
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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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Month 3 postoperative, Month 6 postoperative
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Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)
Time Frame: Month 3 postoperative, Month 6 postoperative
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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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Month 3 postoperative, Month 6 postoperative
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Mean Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Time Frame: Month 3 postoperative, Month 6 postoperative
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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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Month 3 postoperative, Month 6 postoperative
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Mean Binocular Distance Corrected Near Visual Acuity (DCNVA)
Time Frame: Month 3 postoperative, Month 6 postoperative
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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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Month 3 postoperative, Month 6 postoperative
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Percentage of Eyes With Secondary Surgical Interventions (SSIs), by Category
Time Frame: Up to Month 6 postoperative
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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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Up to Month 6 postoperative
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Percentage of Subjects With a Severe Visual Disturbance
Time Frame: Preoperative, Month 3 postoperative, Month 6 postoperative
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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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Preoperative, Month 3 postoperative, Month 6 postoperative
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Percentage of Subjects With a Most Bothersome Visual Disturbance (QUVID)
Time Frame: Preoperative, Month 3 postoperative, Month 6 postoperative
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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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Preoperative, Month 3 postoperative, Month 6 postoperative
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Percentage of Subjects With Ocular Serious Adverse Events Including Serious Adverse Device Effects
Time Frame: Up to Month 6 postoperative
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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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Up to Month 6 postoperative
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Percentage of Subjects With Nonocular Serious Adverse Events Including Serious Adverse Device Effects
Time Frame: Up to Month 6 postoperative
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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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Up to Month 6 postoperative
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sr. Clinical Trial Lead, CDMA Surgical, Alcon Research, LLC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILX140-P001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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