Hydrophobic Acrylic Toric IOL Designed to Reduce the Effects of Preoperative Corneal Astigmatism
Sponsored by Bausch & Lomb Incorporated
About this trial
Last updated 6 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 9 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
* Subjects must have a clinically significant cataract in the study eye that is considered amenable to treatment with standard phacoemulsification cataract extraction.
* Subjects must require a lens power from 16.0 D to 27.0 D in the study eye.
* Subjects must be willing to discontinue contact lens wear for the duration of the study and, demonstrate stability prior to biometry and surgery in the study eye.
* Subjects must have a best corrected distance visual acuity (BCDVA) projected to be better than 20/30 after toric IOL implantation in the study eye.
* Subjects must have predicted postoperative corneal astigmatism between 0.90D and 2.40D in the study eye, as determined by the Toric Calculator.
* Subjects must have a minimum preoperative corneal astigmatism of 0.90 D in the study eye.
* Subjects must have a dilated preoperative pupil size greater than or equal to 5.0 mm in the study eye.
Exclusion Criteria
* Subjects who have had previous intraocular or corneal surgery in the study eye.
* Subjects with any clinically significant ocular pathology which would be expected to reduce potential BCDVA to 20/30 or worse in the study eye during the course of the study.
* Subjects with any anterior segment pathology in the study eye likely to increase the risk of complications from phacoemulsification cataract surgery.
* Subjects with associated ocular conditions which could affect the stability of the IOL in the study eye.
* Subjects with a traumatic cataract in the study eye.
* Subjects with uncontrolled glaucoma in the study eye.
* Subjects with clinically significant irregular corneal astigmatism in the study eye, as determined by the medical judgment of the Investigator.
* Subjects with clinically significant corneal pathology potentially affecting topography of either eye.
* Subjects with any ocular condition that could prevent the possibility of a visual outcome better than 20/30 in the study eye.
* Subjects with a difference of greater than 0.50D of corneal astigmatism as measured with the IOL Master and the topographer in the study eye using vector analysis.
* Subjects with an anterior chamber depth <2mm in the study eye.
* Subjects with potential BCDVA of 20/200 or worse in the fellow eye.