A Prospective, Randomized, Comparative Evaluation of Patients with Contralateral Implantation of Two Aspheric Acrylic Intraocular Lenses R. Cionni, MD.

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Presentation transcript:

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 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 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 Rate ease of implantation Rate control of delivery Rate precision of placement Rate overall performance of the delivery system Additional Comments Ease of Implantation Questionnaire Interim 3 mo = 9 pts

Results Ease of advancing the IOL through the delivery system: Surgeons’ rating Ease of Advancing the Lens Lowest 15 Highest Percentage 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

Results Ease of IOL implantation: Surgeons’ rating Ease of IOL Implantation Percentage Rating Score Lowest 15 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

Results Control of IOL delivery: Surgeons’ rating Control of IOL Delivery Percentage Rating Score Lowest 15 Highest 0% 66.7% 33.3% 0% 100% Results represent the response of 2 surgeons on 8 SN60WF and 9 ZCB00 surgeries

Results Precision of IOL placement: Surgeons’ rating Precision of IOL Placement Percentage Rating Score Lowest 15 Highest 22.2% 0% 100% 77.8% Results represent the response of 2 surgeons on 8 SN60WF and 9 ZCB00 surgeries

Results Overall performance of the delivery system: Surgeons’ rating Overall Performance of the Delivery System Percentage Rating Score Lowest 15 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

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

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