Clinical trial NCT03733730: Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
Official title: Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Presbyopia
Astigmatism
Keywords: cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2018-11-07
Enrollment: 2449
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1 completed prior to the initiation of Arm 2. Within each arm, IOL assignment was parallel.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2
timeFrame: Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
measure: Rate of Eyes With Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2
timeFrame: Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
Secondary outcomes:
measure: Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - By Eye - Cohort 2
timeFrame: Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
measure: Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - Overall Eyes - Cohort 2
timeFrame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
measure: Rate of Eyes With Acute Postoperative Endophthalmitis - By Eye - Cohort 2
timeFrame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
measure: Rate of Eyes With Acute Postoperative Endophthalmitis - Overall Eyes - Cohort 2
timeFrame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
measure: Rate of Eyes With Chronic Postoperative Endophthalmitis - By Eye - Cohort 2
timeFrame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
measure: Rate of Eyes With Chronic Postoperative Endophthalmitis - Overall Eyes - Cohort 2
timeFrame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
measure: Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - By Eye - Cohort 2
timeFrame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
measure: Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2
timeFrame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Trinity Research Group
state: Alabama
city: Phoenix
country: United States
facility: Eye Doctors of Arizona
state: Arizona
city: Fresno
country: United States
facility: InSight Vision Center
state: California
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Torrance
country: United States
facility: Wolstan Goldberg Eye Associates
state: California
city: Fort Collins
country: United States
facility: Eye Center of Northern Colorado, PC
state: Colorado
city: Deerfield Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: DeLand
country: United States
facility: Central Florida Eye Specialists
state: Florida
city: Mount Dora
country: United States
facility: Mid Florida Eye Center
state: Florida
city: Sebring
country: United States
facility: Newsom Eye and Laser Center
state: Florida
city: Sunrise
country: United States
facility: SightTrust Eye Institute
state: Florida
city: Gainesville
country: United States
facility: Gainesville Eye Associates
state: Georgia
city: Leawood
country: United States
facility: Sabates Eye Center
state: Kansas
city: Overland Park
country: United States
facility: Durrie Vision
state: Kansas
city: Louisville
country: United States
facility: Senior Health Services
state: Kentucky
city: Shreveport
country: United States
facility: Willis-Knighton Eye Institute South
state: Louisiana
city: Bloomington
country: United States
facility: Chu Vision Institute
state: Minnesota
city: Stillwater
country: United States
facility: Associated Eye Care
state: Minnesota
city: Kansas City
country: United States
facility: Moyes Eye Center
state: Missouri
city: Town And Country
country: United States
facility: St. Louis Eye Institute
state: Missouri
city: New York
country: United States
facility: Raymond Fong Eye Care
state: New York
city: Poughkeepsie
country: United States
facility: Seeta Eye Center
state: New York
city: Southern Pines
country: United States
facility: Carolina Eye Associates
state: North Carolina
city: Fargo
country: United States
facility: Bergstrom Eye Research
state: North Dakota
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Nashville
country: United States
facility: Vision for Life
state: Tennessee
city: Arlington
country: United States
facility: Kleinman Evangelista Eye Center of Texas
state: Texas
city: Austin
country: United States
facility: Keystone Research
state: Texas
city: El Paso
country: United States
facility: El Paso Eye Surgeons
state: Texas
city: Fort Worth
country: United States
facility: Chu Eye Institute
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Houston
country: United States
facility: Berkeley Eye Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Alkek Eye Center
state: Texas
city: Salt Lake City
country: United States
facility: The Eye Institute of Utah
state: Utah
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Roanoke
country: United States
facility: Vistar Eye Center
state: Virginia
city: Seattle
country: United States
facility: Northwest Eye Surgeons
state: Washington
city: San Juan
country: Puerto Rico
facility: Centro Oftalmologico Metropolitano
Study officials:
affiliation: Alcon Research
name: Sr. Clinical Trial Lead, CRD Surgical
role: STUDY_DIRECTOR
References: