AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0] in Japan

Alcon

Status

Completed

Conditions

Cataracts

Treatments

Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01605877

J-11-037

Details and patient eligibility

About

The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] in Japanese cataract patients.

Full description

Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 8 postoperative visits (each eye examined at Day 1-2, Day 7-14, and Day 30-60, with binocular visits at Day 120-180 and Day 330-420 after the second implantation). The second implantation occurred within 30 days of the first.

Enrollment

70 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Sign informed consent;
Diagnosed with bilateral cataracts;
Planned cataract removal by phacoemulsification;
Potential postoperative visual acuity of 0.5 decimal or better in both eyes;
Preoperative astigmatism ≤ 1.5 diopter;
Clear intraocular media other than cataract in study eyes;
Calculated lens power within the available range;
Able to undergo second eye surgery within 30 days of the first eye surgery;
Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Significant irregular corneal aberration as demonstrated by corneal topography;
Any inflammation or edema (swelling) of the cornea;
Diagnosed degenerative visual disorders predicted to cause future acuity losses to a level worse than 0.5 decimal;
Diabetic retinopathy;
Previous refractive surgery, retinal detachment, corneal transplant;
Glaucoma;
Pregnancy;
Currently participating in another investigational drug or device study;
Exclusion criteria during surgery;
Other protocol-defined exclusion criteria may apply.