1. 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.

2. 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

3. 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 (n =33)
Tecnis ZMB00 1-Piece (n =31)

4. 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

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

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

7. 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

8. 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

9. 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

10. Conclusion
Subjects in the IQ ReSTOR 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 group compared with Tecnis ZMB00 group (p= 0.03). However, no significant differences were noted in trouble with night task between the two groups

11. Conclusion
Subjects in the IQ ReSTOR 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