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

Alcon

Status: Completed

Conditions: Astigmatism; Presbyopia; Aphakia

Treatments: Procedure: Cataract Surgery; Device: ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL; Device: ACRYSOF IQ RESTOR +2.5 D Multifocal IOL; Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT03733730

ILR431b-P001

P040020 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,449 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,449 participants in 2 patient groups

Cohort 1

Experimental group

Description:

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.

Treatment:

Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL

Device: ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL

Procedure: Cataract Surgery

Cohort 2

Experimental group

Description:

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.

Treatment:

Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL

Device: ACRYSOF IQ RESTOR +2.5 D Multifocal IOL

Procedure: Cataract Surgery