N/A N=65 Treatment

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

Cataracts

Bottom Line

View on ClinicalTrials.gov: NCT01323777 ↗

Enrolled (actual)

Serious AEs

12.3%

Results posted

Mar 2017

Primary outcome: Primary: Monocular Uncorrected Distance Decimal Visual Acuity — 3; 3; 1; 0 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL (Device)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Monocular Uncorrected Distance Decimal Visual Acuity	3; 3; 1; 0; 1; 12	—
PRIMARY Monocular Uncorrected Near Decimal VA	1; 0; 1; 64; 65; 64	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01323777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.