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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Investigation of the Visual Outcomes and Safety of AcrySof® IQ PanOptix® Toric Trifocal IOLs in an Asian Population

Conditions
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Aphakia, Corneal Astigmatism

Intervention / Treatment
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* Device: ACRYSOF® IQ PanOptix® Toric Trifocal IOL
* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PanOptix Toric Trifocal IOL<br>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<br>* 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.<br>* Other names: Models TFNT30, TFNT40, TFNT50, TFNT60;Procedure: Cataract surgery<br>* Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular lens, Cataract