Status:
COMPLETED
ACRYSOF® Toric NATURAL T9 Intraocular Lens (IOL)
Lead Sponsor:
Alcon Research
Conditions:
Bilateral Cataract
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of this study is to describe rates of spatial distortions related to intraocular lens (IOL) misalignment for ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 when implanted bilaterally...
Eligibility Criteria
Inclusion
- Adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts;
- Calculated lens power is 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 study eyes;
- Preoperative astigmatism of 4.11 - 4.62 Diopter (D) of predicted crossed cylinder as calculated by the study specific web-based Alcon® Toric IOL Calculator in the first operative eye. Corneal incisions made to reduce astigmatism will not be allowed during the course of the study;
- Preoperative astigmatism of 3.60 - 4.62 D of predicted crossed cylinder as calculated by study specific web-based Alcon® Toric IOL Calculator in the second operative eye;
- Clear intraocular media other than cataract;
- Able to comprehend and sign a statement of informed consent;
- Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR;
- Pupil size greater than or equal to 6 mm after dilation;
- The subject must be able to undergo second eye surgery within 30 days of first eye surgery.
Exclusion
- Irregular corneal astigmatism;
- Keratopathy/Keratectasia - any corneal abnormality, other than regular corneal astigmatism, including but not limited to the following; keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and corneal plana;
- Any inflammation or edema (swelling) of the cornea, including but not limited to the following; keratitis, keratoconjunctivitis, and keratouveitis;
- Previous corneal refractive surgery;
- Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logMAR;
- 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;
- Uncontrolled glaucoma;
- Aniridia;
- Optic nerve atrophy;
- Pregnancy;
- Any subject currently participating in another investigational drug or device study that may confound the results of this investigation.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00967473
Start Date
August 1 2009
End Date
May 1 2010
Last Update
January 9 2017
Active Locations (1)
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1
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134