N/A
Completed N=65
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL) Clinical Study in Japan
Cataracts
Source: ClinicalTrials.gov NCT01323777 ↗
Enrolled (actual)
65
Serious AEs
12.3%
Results posted
Mar 2017
Primary outcomePrimary: Monocular Uncorrected Distance Decimal Visual Acuity — 3; 3; 1; 0 participants
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.
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 | — |
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.
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. Informational only — not medical advice.