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R. Cionni, MD

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.

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R. Cionni, MD

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  1. 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.

  2. 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

  3. 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)

  4. 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

  5. Patients and Methods Ease of Implantation Questionnaire Interim data @ 3 mo = 9 pts

  6. Results Ease of advancing the IOL through the delivery system: Surgeons’ rating 87.5% 56.6% Percentage 22.2% 12.5% O% Rating Score Lowest 1 5 Highest Ease of Advancing the Lens Results represent the response of 2 surgeons on 8 SN60WF and 9 ZCB00 surgeries

  7. Results Ease of IOL implantation: Surgeons’ rating 87.5% 66.7% Percentage 33.3% 12.5% 0% 0% Rating Score Lowest 1 5 Highest Ease of IOL Implantation Results represent the response of 2 surgeons on 8 SN60WF and 9 ZCB00 surgeries

  8. Results 100% Control of IOL delivery: Surgeons’ rating 66.7% Percentage 33.3% 0% 0% 0% Rating Score Lowest 1 5 Highest Control of IOL Delivery Results represent the response of 2 surgeons on 8 SN60WF and 9 ZCB00 surgeries

  9. Results 100% Precision of IOL placement: Surgeons’ rating 77.8% Percentage 22.2% 0% 0% 0% Rating Score Lowest 1 5 Highest Precision of IOL Placement Results represent the response of 2 surgeons on 8 SN60WF and 9 ZCB00 surgeries

  10. Results 87.5% Overall performance of the delivery system: Surgeons’ rating 77.8% Percentage 22.2% 12.5% 0% 0% Rating Score Lowest 1 5 Highest Overall Performance of the Delivery System Results represent the response of 2 surgeons on 8 SN60WF and 9 ZCB00 surgeries

  11. Results 20/200 NS/UP 3 -Month Post-Operative Uncorrected Visual Acuity (UCVA) 20/125 20/80 LogMAR Snellen NS/UP 20/50 NS/UP 20/32 N=9 N=9 N=9 N=9 N=8 N=8 20/20 NS/UP: Non-statistical difference/under powered

  12. 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

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