Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
- Conditions
- AstigmatismAphakiaPresbyopia
- Interventions
- Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOLDevice: ACRYSOF IQ RESTOR +2.5 D Multifocal IOLDevice: ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOLProcedure: Cataract Surgery
- Registration Number
- NCT03733730
- Lead Sponsor
- Alcon Research
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2449
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL 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. Cohort 2 ACRYSOF IQ RESTOR +2.5 D Multifocal IOL 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. Cohort 1 ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL 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. Cohort 1 Cataract Surgery 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. Cohort 2 ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL 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. Cohort 2 Cataract Surgery 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.
- Primary Outcome Measures
Name Time Method Rate of Eyes With Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2 Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye. 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.
Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2 Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye. 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.
- Secondary Outcome Measures
Name Time Method Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - Overall Eyes - Cohort 2 Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first 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.
Rate of Eyes With Acute Postoperative Endophthalmitis - By Eye - Cohort 2 Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first 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.
Rate of Eyes With Chronic Postoperative Endophthalmitis - By Eye - Cohort 2 Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first 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.
Rate of Eyes With Chronic Postoperative Endophthalmitis - Overall Eyes - Cohort 2 Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first 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.
Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2 Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first 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.
Rate of Eyes With Acute Postoperative Endophthalmitis - Overall Eyes - Cohort 2 Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first 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.
Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - By Eye - Cohort 2 Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first 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.
Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - By Eye - Cohort 2 Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye. 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.
Trial Locations
- Locations (38)
Associated Eye Care
🇺🇸Stillwater, Minnesota, United States
Kleinman Evangelista Eye Center of Texas
🇺🇸Arlington, Texas, United States
Berkeley Eye Center
🇺🇸Houston, Texas, United States
Eye Doctors of Arizona
🇺🇸Phoenix, Arizona, United States
Vision for Life
🇺🇸Nashville, Tennessee, United States
The Eye Institute of Utah
🇺🇸Salt Lake City, Utah, United States
SightTrust Eye Institute
🇺🇸Sunrise, Florida, United States
Gainesville Eye Associates
🇺🇸Gainesville, Georgia, United States
Sabates Eye Center
🇺🇸Leawood, Kansas, United States
Durrie Vision
🇺🇸Overland Park, Kansas, United States
Trinity Research Group
🇺🇸Dothan, Alabama, United States
InSight Vision Center
🇺🇸Fresno, California, United States
Harvard Eye Associates
🇺🇸Laguna Hills, California, United States
Eye Center of Northern Colorado, PC
🇺🇸Fort Collins, Colorado, United States
Wolstan Goldberg Eye Associates
🇺🇸Torrance, California, United States
Rand Eye Institute
🇺🇸Deerfield Beach, Florida, United States
Central Florida Eye Specialists
🇺🇸DeLand, Florida, United States
Mid Florida Eye Center
🇺🇸Mount Dora, Florida, United States
Newsom Eye and Laser Center
🇺🇸Sebring, Florida, United States
Willis-Knighton Eye Institute South
🇺🇸Shreveport, Louisiana, United States
Chu Vision Institute
🇺🇸Bloomington, Minnesota, United States
St. Louis Eye Institute
🇺🇸Town And Country, Missouri, United States
Seeta Eye Center
🇺🇸Poughkeepsie, New York, United States
Raymond Fong Eye Care
🇺🇸New York, New York, United States
Bergstrom Eye Research
🇺🇸Fargo, North Dakota, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Carolina Eye Associates
🇺🇸Southern Pines, North Carolina, United States
El Paso Eye Surgeons
🇺🇸El Paso, Texas, United States
Chu Eye Institute
🇺🇸Fort Worth, Texas, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
Baylor College of Medicine Alkek Eye Center
🇺🇸Houston, Texas, United States
Vistar Eye Center
🇺🇸Roanoke, Virginia, United States
Piedmont Eye Center
🇺🇸Lynchburg, Virginia, United States
Northwest Eye Surgeons
🇺🇸Seattle, Washington, United States
Centro Oftalmologico Metropolitano
🇵🇷San Juan, Puerto Rico
Senior Health Services
🇺🇸Louisville, Kentucky, United States
Moyes Eye Center
🇺🇸Kansas City, Missouri, United States
Keystone Research
🇺🇸Austin, Texas, United States