A Prospective, Randomized, Comparative Evaluation of Patients with Contralateral Implantation of Two Aspheric Acrylic Intraocular

Lenses

R. Cionni, MD

Consultant, Alcon Laboratories, Inc.

Alcon sponsored the study and provided statistical and presentation support.

Background and Purpose

• The optical advantages of aspheric intraocular lens (IOL) technology have become fairly well accepted in ophthalmology practice

• However, some controversy still remains in the areas of functional benefit as it relates to pupil size, IOL decentration, depth of focus and customization

• The primary objective of this randomized study is to evaluate prospectively the postoperative outcomes of two different aspheric acrylic intraocular lenses

Patients and Methods

• Prospective, randomized, patient-masked, dual-center study

• Target N = 20 • Subjects ≥21 years of age with good

ocular health and in need of bilateral cataract extraction

• <1.0 D of astigmatism in both eyes• Interim data @ 3mo• Contralateral implantation of aspheric

Acrylic Tecnis (ZCB00) 1-Piece IOL (N=9) and the AcrySof Natural IQ (SN60WF) IOL (N=9)

Patients and Methods

Assessment• The surgeon experience with ease of

implantation was evaluated by a subjective questionnaire completed immediately upon conclusion of the surgery

• Assessment included LogMAR UCVA, lens rotation, PCO and ACO readings at 1 month and 3-months post- operatively

• Interim analysis @ 3 mo

Patients and Methods

Surgical Evaluation: Circle one choice for each question.Satisfaction Rankings: 1 = Lowest (Poor) 5 = Highest (Very Good) 1. Rate ease of advancing the lens through the delivery system 1 2 3 4 52. Rate ease of implantation 1 2 3 4 53. Rate control of delivery 1 2 3 4 54. Rate precision of placement 1 2 3 4 55. Rate overall performance of the delivery system 1 2 3 4 5Additional Comments

Ease of Implantation Questionnaire

Interim data @ 3 mo = 9 pts

ResultsEase of advancing the IOL through the delivery system: Surgeons’ rating

3 4 50

20

40

60

80

100SN60WF ZCB00

22.2%

Ease of Advancing the Lens

Lowest 1 5 Highest

Perc

en

tag

e

Rating Score

O%

56.6%

87.5%

22.2%12.5

%

Results represent the response of 2 surgeons on 8 SN60WF and 9 ZCB00 surgeries

ResultsEase of IOL implantation: Surgeons’ rating

Ease of IOL Implantation

Perc

en

tag

e

Rating Score

3 4 50

20

40

60

80

100SN60WF ZCB00

Lowest 1 5 Highest

66.7%

12.5%

0%

33.3%

87.5%

0%

Results represent the response of 2 surgeons on 8 SN60WF and 9 ZCB00 surgeries

ResultsControl of IOL delivery: Surgeons’ rating

Control of IOL Delivery

Perc

en

tag

e

Rating Score

3 4 50

20

40

60

80

100SN60WF ZCB00

Lowest 1 5 Highest

0%

66.7%

33.3%

0% 0%

100%

Results represent the response of 2 surgeons on 8 SN60WF and 9 ZCB00 surgeries

ResultsPrecision of IOL placement: Surgeons’ rating

Precision of IOL Placement

Perc

en

tag

e

Rating Score3 4 5

0

20

40

60

80

100SN60WF ZCB00

Lowest 1 5 Highest

22.2%

0%0% 0%

100%

77.8%

Results represent the response of 2 surgeons on 8 SN60WF and 9 ZCB00 surgeries

ResultsOverall performance of the delivery system: Surgeons’ rating

Overall Performance of the Delivery System

Perc

en

tag

e

Rating Score

3 4 50

20

40

60

80

100SN60WF ZCB00

Lowest 1 5 Highest

22.2%

77.8%

12.5%

0%

87.5%

0%

Results represent the response of 2 surgeons on 8 SN60WF and 9 ZCB00 surgeries

Results3 -Month Post-Operative Uncorrected Visual Acuity (UCVA)

Preop 1 Month 3 Months0.00

0.20

0.40

0.60

0.80

SN60WF ZCB00NS/UP

NS/UPNS/UP

N=9 N=9 N=9 N=9 N=8 N=8

NS/UP: Non-statistical difference/under powered

LogM

AR20/200

20/125

20/80

20/20

20/50

20/32

Snel

len

Conclusion• Overall performance of the delivery system

showed better surgeons’ rating for SN60WF IOLs compared with ZCB00 IOLs.• Subcategories all favored SN60WF vs. ZCB00

• Ease of implantation• Delivery control• Precision of placement • Ease of advancing the IOL

• Due to small sample size of interim data, the statistical differences on the LogMAR UCVA, rotational stability, PCO and ACO could not be established between the SN60WF and ZCB00 IOLs.

Note: Lens of choice for participating surgeons is the SN60WF