Bret Fisher, MD The Eye Center of North Florida Panama City, FL Subjective Visual Function Outcomes after Bilateral Implantation of Diffractive Presbyopia Correcting IOLs Bret Fisher, MD The Eye Center of North Florida Panama City, FL Alcon Laboratories, Inc. Alcon sponsored the study and provided statistical and presentation support.

Background and Purpose Advances in intraocular lens (IOL) technology for the correction of presbyopia have led to significant improvements in patient reported outcomes Presbyopia-correcting IOLs provide good vision at a range of distances without the need for eye glasses The primary objective of the current study was to assess prospectively patient perceived experience of near, intermediate, and distant range tasks before and after bilateral implantation of the IQ ReSTOR +3.0 and the Tecnis ZMB00 1-Piece multifocal IOLs

Patients and Methods Prospective, randomized multi-center, 3-month trial 4 U.S. study centers Subjects ≥ 21 years with bilateral cataract Bilateral implantation of multifocal IOL IQ ReSTOR + 3.0 (n =33) Tecnis ZMB00 1-Piece (n =31)

Patients and Methods Assessment The Visual Task Difficulty Assessment (VISTAS) questionnaire was conducted 1 to 6-point scale was used with the following possible responses on visual task 1 = no difficulty 2 = minor difficulty 3 = moderate difficulty 4 = major difficulty 5 = cannot accomplish 6 = not applicable

Patients and Methods Assessment Patient-reported outcomes on tasks Near Vision Intermediate Vision Distant Vision 1 month interim results are reported

Results Demographics Variable IQ ReSTOR + 3.0 Tecnis ZMB00 Total patients 33 31 Age (Mean + SD) 63.67 + 9.78 65.13 + 6.8 Male 14 11 Female 19 20

Patient-reported outcomes w/o correction (Mean + SD) Results Patient-reported outcomes w/o correction (Mean + SD) VISTAS rating Increasing difficulty N=20 N=24 1- 6 point scale: 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish ; 6 = not applicable

Patient-reported outcomes - Uncorrected vision (Mean + SD) Results Patient-reported outcomes - Uncorrected vision (Mean + SD) Increasing difficulty Difficulty Rating 0- 4 point scale: 0 = no trouble at all; 1= A little bit of trouble; 2 = Moderate trouble; 3 = Considerate trouble; 4 = Major or overwhelming trouble

Patient-reported outcomes - Uncorrected vision (Mean + SD) Results Patient-reported outcomes - Uncorrected vision (Mean + SD) Higher Satisfaction Satisfaction Rating 0- 4 point scale: 0 = not at all satisfied; 1= A little satisfied; 2 = Moderately satisfied; 3 = Mostly satisfied; 4 = Completely Satisfied

Conclusion Subjects in the IQ ReSTOR + 3.0 group had significantly less difficulty in performing near (p = 0.026) and intermediate (p = 0.009) vision tasks effectively and safely compared with those in the Tecnis ZMB00 group Subjects with IQ ReSTOR +3.0 IOL reported less difficulty with their ability to drive safely and confidently at night than those with the Tecnis ZMB00 IOL (p = 0.018) Trouble with daytime task was significantly lower in the IQ ReSTOR + 3.0 group compared with Tecnis ZMB00 group (p= 0.03). However, no significant differences were noted in trouble with night task between the two groups

Conclusion Subjects in the IQ ReSTOR + 3.0 group reported significantly higher satisfaction with vision task during day (p = 0.017) as well as at night (p = 0.027) compared with those in the Tecnis ZMB00 group Overall, patient reported outcomes with VISTAS questionnaire provide valuable information about IOL performance for tasks at far, intermediate, and near distances