Clinical Investigation of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

Alcon

Status

Completed

Conditions

Cataracts

Treatments

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

Device: AcrySof® ReSTOR® Multifocal IOL Model SA60D3

Study type

Interventional

Funder types

Industry

Identifiers

NCT01424189

C-09-036

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of an investigational multifocal toric intraocular lens (IOL) compared to an FDA-approved multifocal IOL.

Full description

Participants 21 years and older within the targeted astigmatism range and in need of cataract extraction in both eyes were consented and randomized in a 2:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® Multifocal Toric IOL or the control AcrySof® ReSTOR® Multifocal IOL in both eyes. Each participant completed a preoperative examination of both eyes, implantation of the IOL at the operative visit for each eye, and up to 8 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60 and binocular testing at Day 120-180 and Day 340-420/Visit 5 following the second implantation. The eye with the greater amount of astigmatism was implanted first (first operative eye). The second eye implant was intended to occur within 30 days after the first eye implant but not prior to 7 days after the first eye implant. Both eyes needed to qualify under inclusion/exclusion criteria at the preoperative visit. If the first eye was excluded during surgery, the second eye was not eligible. If the second eye was excluded during surgery, only the first eye was followed.

Enrollment

677 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed with bilateral cataracts;
Able to comprehend and sign a statement of informed consent;
Calculated lens power and astigmatism within the available range;
Willing and able to complete all required postoperative visits;
Planned cataract removal by phacoemulsification;
Potential postoperative visual acuity of 0.2 logMAR or better in both eyes;
Preoperative astigmatism in both operative eyes as described in the clinical protocol; Note: Corneal incisions made to reduce astigmatism will not be allowed during the course of the study.
Clear intraocular media other than cataract in study eyes;
Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR in each eye;
Pupil size greater than or equal to 6 mm after dilation;
Able to undergo second eye surgery within 30 days of the first eye surgery;
Other protocol-specified inclusion criteria may apply.

Exclusion criteria

Significant irregular corneal aberration as demonstrated by corneal topography;
Keratopathy/Kerectasia - any corneal abnormality, other than regular corneal astigmatism;
Any inflammation or edema (swelling) of the cornea;
Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted (by subjective assessment of the retina) to cause future acuity losses to a level worse than 0.2 logMAR;
Reasonably expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy);
Previous corneal refractive surgery;
Amblyopia;
Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy);
Diabetic retinopathy;
Extremely shallow anterior chamber, not due to swollen cataract;
Microphthalmos;
Previous retinal detachment;
Previous corneal transplant;
Recurrent severe anterior or posterior segment inflammation of unknown etiology;
Rubella or traumatic cataract;
Iris neovascularization;
Glaucoma (uncontrolled or controlled with medication);
Aniridia;
Optic nerve atrophy;
Pregnancy;
Current participation in another investigational drug or device study that may confound the results of this investigation;
Other planned ocular surgery procedures, including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions, for the duration of the study;
Other protocol-specified exclusion criteria may apply.