Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses

The purpose of this study is to characterize the safety and effectiveness of the ACRYSOF IQ ReSTOR +2.5 diopter (D) Multifocal Toric Intraocular Lens (IOL) in subjects at least 3 months and no more than 14 months after IOL implantation.

Study Overview

• Status: Completed
• Conditions: Cataract; Presbyopia; Corneal Astigmatism
• Intervention / Treatment: Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL

Detailed Description

This is a retrospective and prospective clinical study comprised of a retrospective chart review for preoperative, surgical and early postoperative data, and a prospective postoperative visit conducted at least 3 months but not more than 14 months after IOL implantation.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must sign an informed consent form and be willing to come in for a visit at least 3 months and not more than 14 months after IOL implantation with the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL (Models SV25T2, SV25T3, SV25T4 and SV25T5);
• Must be implanted with the correct lens based on preoperative corneal astigmatism as specified in the protocol;
• Must complete a visit within 10 days after IOL implantation;
• Successful capsular bag implantation with no surgical complications;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• IOL implanted prior to the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL;
• Ocular or intraocular infection or inflammation at the time of the preoperative visit;
• Any ocular surgery or intraocular laser procedure at or prior to the surgical visit;
• Any conditions affecting the cornea (eg. corneal dystrophy, severe dry eye) at the preoperative visit;
• Retinal conditions (e.g. degenerative retinal conditions, history of retinal detachment, diabetic retinopathy) at the preoperative visit;
• Known history of Type 1 or 2 diabetes for more than 5 years;
• Any ocular or systemic co-morbidity at the preoperative visit;
• Pregnant at the preoperative visit or at the time of Postoperative Visit 2;
• Preoperative corneal astigmatism ≤ 0.50 D;
• Participation in another clinical study at the preoperative visit or at the time of the final study visit;
• Other protocol-specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ReSTOR Toric +2.5; AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL previously implanted during cataract surgery	Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL; Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient; Other Names: Model SV25T2; Model SV25T3; Model SV25T4; Model SV25T5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Reduction in Cylinder	Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder [defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder], multiplied by 100%. One eye (primary eye) contributed to the analysis.	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D	Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D	Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Mean Uncorrected Distance Visual Acuity	Visual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Mean Uncorrected Near Visual Acuity	VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Mean Uncorrected Intermediate Visual Acuity	VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Mean Best Corrected Distance Visual Acuity (BCDVA)	VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Mean IOL Rotation	Lens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis.	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Manager, GCRA, Surgical, Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2014
• Primary Completion (Actual): August 22, 2014
• Study Completion (Actual): August 22, 2014

Study Registration Dates

• First Submitted: June 25, 2014
• First Submitted That Met QC Criteria: June 25, 2014
• First Posted (Estimate): June 27, 2014

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Cataract; Intraocular lens; ACRYSOF IQ ReSTOR + 2.5 D Multifocal Toric IOL
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia; Astigmatism
• Other Study ID Numbers: C-14-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes