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

NCT ID: NCT02176343

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-21
• Study Completion Date: 2014-08-22

Brief Summary

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.

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.

Conditions

Cataract; Presbyopia; Corneal Astigmatism

Study Design

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

Study Groups

ReSTOR Toric +2.5

AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL previously implanted during cataract surgery

Group Type: EXPERIMENTAL

AcrySof® IQ ReSTOR® +2.5 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® +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

Intervention Type: DEVICE

Other Intervention Names

Model SV25T2; Model SV25T3; Model SV25T4; Model SV25T5

Eligibility Criteria

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;

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;

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

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Manager, GCRA, Surgical

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-14-005

Identifier Type: -

Identifier Source: org_study_id