Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

NCT ID: NCT01200511

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-09-30

Brief Summary

The purpose of this study is to describe visual outcomes, in particular spherical equivalent by manifest refraction and visual acuity across a range of distances, 6 months post implantation of the AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in adult patients with corneal astigmatism. Additionally, patient reported outcomes will be assessed.

Detailed Description

Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 5 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1, Month 3, and Month 6 after the second implantation). The second implantation generally occurred within 30 days of the first.

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ReSTOR +3.0

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation

Group Type: EXPERIMENTAL

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL

Intervention Type: DEVICE

Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient

Interventions

AcrySof® IQ ReSTOR® +3.0 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

Intervention Type: DEVICE

Other Intervention Names

Models SND1T3, SND1T4, SND1T5

Eligibility Criteria

Inclusion Criteria

• Sign informed consent;
• Require cataract extraction followed by posterior IOL implantation or eligible for refractive lens exchange (RLE) in both eyes;
• Able to undergo second eye surgery within one month (30 days) of first eye surgery;
• Able to attend postoperative examinations per protocol schedule;
• Qualify for a AcrySof IQ Toric IOL in both eyes;
• Preoperative astigmatism of ≥0.75 to ≤2.5 diopters (D) in both eyes;
• Residual refractive cylinder of ≤0.5 D in both eyes;
• Good ocular health;

Exclusion Criteria

• Planned multiple procedures, including LRI, during cataract/IOL implantation surgery;
• Amblyopia;
• Previous corneal surgery;
• Clinically significant corneal endothelial dystrophy;
• History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
• History of retinal detachment;
• Pregnant or planning to become pregnant during course of study;

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brand Lead, Surgical, Global Medical Affairs

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

M09-052

Identifier Type: -

Identifier Source: org_study_id