Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,449
- 试验地点
- 38
- 主要终点
- Rate of Eyes With Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
Cohort 2
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.
干预措施: Cataract Surgery (Procedure)
Cohort 2
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.
干预措施: ACRYSOF IQ RESTOR +2.5 D Multifocal IOL (Device)
Cohort 1
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.
干预措施: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL (Device)
Cohort 1
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.
干预措施: ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL (Device)
Cohort 1
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.
干预措施: Cataract Surgery (Procedure)
Cohort 2
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.
干预措施: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL (Device)
结局指标
主要结局
Rate of Eyes With Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2
时间窗: 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
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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.)