Post Approval Study of the AcrySof IQ Toric High Cylinder Power Intraocular Lens (IOL)

Study ID
STU 072012-073

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other

Contact
Janie Burroughs
214-645-2012
janie.burroughs@utsouthwestern.edu

Principal Investigator
Robert Bowman

Summary

There are 2 arms in this study. one control arm - High astigmats that choose an aspheric ioL and astigmatic spectacles to clear the near and distant images, anD the High astigmatic ioL arm group that inserts the high astigmatism ioL at surgery requiring no spectacles after surgery most likely. Both arms further determine efficacy of the Toric high cylinder ioL by patient subjective questionnaires at the beginning and end of study and objective visual outcome testing as in standard of care when patient comes for pre and post operative assessments.

Participant Eligibility

1. Adults, 21 years of age or older at the time of surgery, diagnosed with bilateral
cataracts and in the targeted astigmatism range;
2. Willing and able to complete all required postoperative visits;
3. Planned cataract removal by phacoemulsification;
4. Preoperative regular astigmatism of >= 2.57 D of predicted crossed cylinder as
calculated by the web-based Alcon AcrySof(RegisteredTM) IQ Toric IOL Calculator in both eyes.
NOTE: Corneal incisions or any other procedures (e.g., Photorefractive keratectomy
[PRK], Laser-Assisted In Situ Keratomileusis [LASIK] and Laser-Assisted Sub-
Epithelial Keratomileusis [LASEK]) made to reduce astigmatism will not be allowed
during the course of the study;
5. Clear intraocular media other than cataract;
6. Able to comprehend and sign a statement of informed consent;
7. Pupil size greater than or equal to 6 mm after dilation;
8. The subject must be able to undergo second eye surgery within 30 days of first eye
surgery.