Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs

Study Overview
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Brief Summary
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This is a prospective, multicenter, post-approval active surveillance study. The purpose of this study is to report the rate of post-surgical intraocular inflammation (based upon a specified case definition) reported within a 180-day post-surgical period following attempted implantation of an ACRYSOF IQ RESTOR Toric or ACRYSOF IQ RESTOR IOL in the US.

Detailed Description
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If a second eye will participate in the study, subjects will receive the second eye cataract surgery within 20 days of the first eye surgery. Four postoperative follow-up visits are planned to occur at 1-2 days, 7-14 days, 30-60 days, and 90-180 days, for each enrolled eye. Subject participation in this study is expected to last up to 7 months, including a total of 6 study visits for subjects implanted in one eye and up to 11 visits for subjects implanted in both eyes. Upon completion of the 180 days follow-up visit, subjects will be exited from the study.

Official Title
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Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs

Conditions
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Aphakia, Presbyopia, Astigmatism

Intervention / Treatment
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* Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL
* Device: ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL
* Device: ACRYSOF IQ RESTOR +2.5 D Multifocal IOL
* Procedure: Cataract Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preoperative cataract in the study eye(s) Planned implantation in at least one eye with: Cohort 1: An ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6) or an ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOLs (Models SV25T3, SV25T4, SV25T5, and SV25T6) in accordance with the product labeling from November 2018 to July 2020 Cohort 2: An ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6), or an ACRYSOF IQ RESTOR +2.5 D Multifocal IOL (Model SV25T0) in accordance with the product labeling after July 2020. Able to comprehend and sign a statement of informed consent Willing and able to complete all required postoperative visits Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Eyes with clinically significant ocular, including adnexa, or intraocular infection or inflammation (at the screening visit prior to surgery or on the day of surgery) History of any intraocular inflammation within the past 12 months (ex: uveitis, choroiditis) Combined procedures introducing an additional medical device during cataract surgery (ex: cataract surgery with implant of glaucoma stent) Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 22 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1 completed prior to the initiation of Arm 2. Within each arm, IOL assignment was parallel.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>ACRYSOF IQ RESTOR Multifocal Toric IOL (+3.0 D or +2.5 D) implanted in at least one eye during cataract surgery, with implantation occurring from November 2018 through July 2020. | Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL<br>* Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual cylinder and increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.<br>* Other names: Models SND1T3, SND1T4, SND1T5, and SND1T6;Device: ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL<br>* Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual cylinder and increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.<br>* Other names: Models SV25T3, SV25T4, SV25T5, and SV25T6;Procedure: Cataract Surgery<br>* Routine small incision cataract surgery with IOL implantation<br>|
| Experimental: Cohort 2<br>ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in at least one eye during cataract surgery, with implantation occurring after July 2020. | Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL<br>* Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual cylinder and increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.<br>* Other names: Models SND1T3, SND1T4, SND1T5, and SND1T6;Device: ACRYSOF IQ RESTOR +2.5 D Multifocal IOL<br>* Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.<br>* Other names: Model SV25T0;Procedure: Cataract Surgery<br>* Routine small incision cataract surgery with IOL implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2 | Post-surgical intraocular inflammation was defined as exacerbated intraocular inflammation within 180 days after IOL implantation, indicated by greater than or equal to 3+ aqueous cell within the first 14 days post-operative, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-operative, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. | Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye. | 
| Rate of Eyes With Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2 | Post-surgical intraocular inflammation was defined as exacerbated intraocular inflammation within 180 days after IOL implantation, indicated by greater than or equal to 3+ aqueous cell within the first 14 days post-operative, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-operative, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. | Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - By Eye - Cohort 2 | TASS was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 3+ aqueous cell, non-infectious etiology, and rapid onset (up to and including 2 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. | Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye. | 
| Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - Overall Eyes - Cohort 2 | TASS was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 3+ aqueous cell, non-infectious etiology, and rapid onset (up to and including 2 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. | Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first | 
| Rate of Eyes With Acute Postoperative Endophthalmitis - By Eye - Cohort 2 | Acute postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater or equal to 3+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous and/or vitreous abscess, and rapid onset (3 to 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. | Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first | 
| Rate of Eyes With Acute Postoperative Endophthalmitis - Overall Eyes - Cohort 2 | Acute postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater or equal to 3+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous and/or vitreous abscess, and rapid onset (3 to 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. | Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first | 
| Rate of Eyes With Chronic Postoperative Endophthalmitis - By Eye - Cohort 2 | Chronic postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 1+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous, and delayed onset (greater than 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. | Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first | 
| Rate of Eyes With Chronic Postoperative Endophthalmitis - Overall Eyes - Cohort 2 | Chronic postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 1+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous, and delayed onset (greater than 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. | Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first | 
| Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - By Eye - Cohort 2 | Uncategorized post-surgical intraocular inflammation was defined as signs of exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings that do not fall in the given category of TASS, Acute Postoperative Endophthalmitis, or Chronic Postoperative Endophthalmitis: Greater than or equal to 3+ aqueous cell within the first 14 days post-op, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-op, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. | Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first | 
| Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2 | Uncategorized post-surgical intraocular inflammation was defined as signs of exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings that do not fall in the given category of TASS, Acute Postoperative Endophthalmitis, or Chronic Postoperative Endophthalmitis: Greater than or equal to 3+ aqueous cell within the first 14 days post-op, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-op, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as Total # of reported events / Total # of implants X 1000. No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only. | Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract