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

Alcon

Status

Completed

Conditions

Cataract

Corneal Astigmatism

Presbyopia

Treatments

Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT02176343

C-14-005

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.