Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses

Primary outcomes

1. Mean Percent Reduction in Cylinder

   Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

   Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder [defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder], multiplied by 100%. One eye (primary eye) contributed to the analysis.

2. Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D

   Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

   Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.

3. Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D

   Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

   Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.

4. Mean Uncorrected Distance Visual Acuity

   Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

   Visual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.

5. Mean Uncorrected Near Visual Acuity

   Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

   VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.

6. Mean Uncorrected Intermediate Visual Acuity

   Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

   VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.

7. Mean Best Corrected Distance Visual Acuity (BCDVA)

   Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

   VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.

8. Mean IOL Rotation

   Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

   Lens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis.