ACRYSOF® Toric NATURAL T9 Intraocular Lens (IOL)
Completed · Not applicable
Conditions studied: Bilateral Cataract
In brief
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 into the capsular bag following phacoemulsification in adult patients with bilateral cataract and regular corneal astigmatism. Subjects were implanted with the Model SN60T9 in the first operative (study) eye and either Model SN60T9 or Model SN60T8 in the second operative eye.
Key facts
- Study ID
- NCT00967473
- Run by
- Alcon Research
- People needed
- 15
- Starts
- 2009-08-01
- Expected to finish
- 2010-05-01
- Last updated by the study team
- 2017-01-09
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Alcon Call Center for Trial Locations — Fort Worth, Texas, United States
Full record on ClinicalTrials.gov
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