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

Alcon

Status: Completed

Conditions: Cataract

Treatments: Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT01200511

M09-052

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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;
• Other protocol-defined inclusion criteria may apply.

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;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

ReSTOR +3.0

Experimental group

Description:

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

Treatment:

Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL