Subjective Visual Function Outcomes after Bilateral Implantation of

Diffractive Presbyopia Correcting IOLs

Bret Fisher, MDThe 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

• 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

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 tasko 1 = no difficultyo 2 = minor difficultyo 3 = moderate difficultyo 4 = major difficultyo 5 = cannot accomplish o 6 = not applicable

Patients and Methods

Assessment• Patient-reported outcomes on tasks

o Near Visiono Intermediate Visiono Distant Vision

• 1 month interim results are reported

ResultsDemographics

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

ResultsPatient-reported outcomes w/o correction (Mean + SD)

1- 6 point scale: 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish ; 6 = not applicable

VIST

AS ra

ting

Effectively & Safely Perform Near Tasks

(< 2 Feet)

Effectively & Safely Perform Intermediate

Tasks (2-3 Feet)

Drive Confidently & Safely at Night

0

1

2

3

4 IQ ReSTOR + 3.0 Tecnis ZMB00

p = 0.026 p = 0.009

p = 0.018

N=20 N=24 N=20 N=24

Incr

easi

ng d

ifficu

lty

N=20 N=24

ResultsPatient-reported outcomes - Uncorrected vision

(Mean + SD)

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

Diffi

culty

Rati

ng

Incr

easi

ng d

ifficu

lty

Trouble with daytime task Trouble with night task0.0

1.0

2.0

3.0IQ ReSTOR + 3.0 Tecnis ZMB00

N=19 N=24 N=20 N=24

P = 0.03

NS

ResultsPatient-reported outcomes - Uncorrected vision

(Mean + SD)Sa

tisfa

ction

Rati

ng

0- 4 point scale: 0 = not at all satisfied; 1= A little satisfied; 2 = Moderately satisfied; 3 = Mostly satisfied; 4 = Completely Satisfied

Hig

her S

atisf

actio

n

Satisfaction w/ vision during day Satisfaction w/ vision during night0

1

2

3

4

5IQ ReSTOR + 3.0 Tecnis ZMB00

P = 0.017 P = 0.027

N=20 N=24 N=20 N=24

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