N/A
Completed N=574
Clinical Investigation of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)
Cataracts
Source: ClinicalTrials.gov NCT01424189 ↗
Enrolled (actual)
574
Serious AEs
11.5%
Results posted
Mar 2017
Primary outcomePrimary: Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5 — 0.126; 0.125 logMAR
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5 |
0.126; 0.125 | — |
| PRIMARY Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5 |
0.19; 0.24 | — |
| PRIMARY Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5 |
1.04; 2.13; 0.52; 2.13 | — |
| SECONDARY Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 |
0.8; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01424189). 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.