Status:
COMPLETED
Clinical Investigation of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)
Lead Sponsor:
Alcon Research
Conditions:
Cataracts
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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.
Detailed Description
Participants 21 years and older within the targeted astigmatism range and in need of cataract extraction in both eyes were consented and randomized in a 2:1 ratio at each investigative site to receive...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
677 Patients enrolled
Trial Details
Trial ID
NCT01424189
Start Date
July 1 2011
End Date
January 1 2013
Last Update
June 29 2018
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