AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL) Clinical Study in Japan

Alcon

Status: Completed

Conditions: Cataracts

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01323777

J-10-050

Details and patient eligibility

About

The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Models SND1T3, SND1T4, SND1T5, and SND1T6 when implanted to replace the natural lens in Japanese cataract patients.

Full description

Eligible participants completed a preoperative examination of both eyes, implantation of the IOL at the operative visit for each eye, and up to 8 postoperative visits: Day 1-2, Day 7-14, and Day 30-60 after each implantation, and Day 120-180 and Day 330-420 after second eye implantation. The second implantation occurred within 30 days of the first.The primary eye was defined as the eye with higher astigmatism, with the other eye defined as the secondary eye. If both eyes had the same level of astigmatism, the first implanted eye was set as the primary eye.

Enrollment: 65 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 0.6 decimal or better in both eyes;
• Preoperative astigmatism ≥ 0.75 diopter;
• Clear intraocular media other than cataract in study eyes;
• Calculated lens power and astigmatism within the available range;
• 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-defined inclusion criteria may apply.

Exclusion criteria

• 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 0.6 decimal;
• Diabetic retinopathy;
• Previous refractive surgery, retinal detachment, corneal transplant;
• Glaucoma;
• Pregnant, nursing, or suspected of being pregnant;
• Currently participating in another investigational drug or device 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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65 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