Subjective Visual Function Outcomes after Bilateral Implantation of

Report
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.
•
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
•
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)
 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
o
1 = no difficulty
o
2 = minor difficulty
o
3 = moderate difficulty
o
4 = major difficulty
o
5 = cannot accomplish
o
6 = not applicable
 Assessment
• Patient-reported outcomes on tasks
o
o
o
Near Vision
Intermediate Vision
Distant Vision
• 1 month interim results are reported
Demographics
Variable
IQ ReSTOR + 3.0
Tecnis ZMB00
33
31
63.67 + 9.78
65.13 + 6.8
Male
14
11
Female
19
20
Total patients
Age (Mean + SD)
Patient-reported outcomes w/o correction (Mean + SD)
IQ ReSTOR + 3.0
VISTAS rating
Increasing difficulty
4
Tecnis ZMB00
p = 0.018
3
p = 0.026
p = 0.009
2
1
0
N=20 N=24
N=20 N=24
N=20 N=24
Effectively & Safely
Effectively & Safely Drive Confidently &
Perform Near Tasks Perform Intermediate
Safely at Night
(< 2 Feet)
Tasks (2-3 Feet)
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)
3.0
Difficulty Rating
Increasing difficulty
IQ ReSTOR + 3.0
Tecnis ZMB00
2.0
NS
P = 0.03
1.0
0.0
N=19
N=24
Trouble with daytime task
N=20
N=24
Trouble with night task
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)
IQ ReSTOR + 3.0
Satisfaction Rating
Higher Satisfaction
5
P = 0.017
Tecnis ZMB00
P = 0.027
4
3
2
1
N=20
N=24
N=20
N=24
0
Satisfaction w/ vision during day
Satisfaction w/ vision during night
0- 4 point scale: 0 = not at all satisfied; 1= A little satisfied; 2 = Moderately satisfied;
3 = Mostly satisfied; 4 = Completely Satisfied
•
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
•
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

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