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Financial Interest Disclosure

Financial Interest Disclosure. I have no financial interest in the devices discussed in this presentation. Presbyopic IOL Calculations: The Aspheric ReSTOR D1 and Crystalens HD. Jonathan M. Davidorf, MD Los Angeles, CA April, 2010. Purpose of Study.

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Financial Interest Disclosure

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  1. Financial Interest Disclosure • I have no financial interest in the devices discussed in this presentation.

  2. Presbyopic IOL Calculations:The Aspheric ReSTOR D1 and Crystalens HD Jonathan M. Davidorf, MD Los Angeles, CA April, 2010

  3. Purpose of Study • To examine the predictability of intraocular lens implant (IOL) calculations in patients undergoing cataract surgery and implantation of the Aspheric ReSTOR D1 or Crystalens HD IOLs.

  4. Background As the goal of presbyopic intraocular lens (IOL) implants is to achieve a maximum level of spectacle independence, highly predictable postoperative refractions are desirable. In the United States, the ReSTOR and Crystalens are the two most commonly implanted presbyopic IOLs. The design of the one-piece hydrophobic acrylic ReSTOR IOL is based on Alcon’s AcrySof platform and is similar to the monofocal IOL, the SN60WF. The predictability of ReSTOR IOL power calculations would be expected to be similar to that of the monofocal SN60WF. The Crystalens, on the other hand, is a silicone IOL with no non-presbyopic correcting counterpart. The Crystalens was designed to move anteriorly and posteriorly inside the eye in order to produce an accommodative effect. The Crystalens HD is similar in design to the earlier Crystalens 5-0 model, with the added design element of an increase in negative spherical aberration in the central 1.5mm of the IOL optic. The design change was intended to increase depth of focus. While the mechanism of action of the Crystalens remains an area of debate, the IOL’s unique design has raised concerns of predictability of power calculations.

  5. Methods • Ongoing, non-randomized, unmasked prospective study • 64 eyes of 33 pts • Standard coaxial phaco/IOL, topical anesthesia • Pts received either Aspheric ReSTOR D1 or Crystalens HD • Only eyes with 20/25 or better postoperative BCVA analyzed. • No prior ocular surgery • Data collected at 1 M, 3M, and 6 M postoperatively

  6. Demographics *no explanation for the gender discrepancy between groups

  7. IOL Calculation Formulas • SRK-T: 2 variable regression formula • Haigis: theoretical formula, surgeon/iol specific constants (“customizable”) Key Statistic:Prediction Error of IOL Calculation formula (1M MRSE – predicted SE)

  8. Results: Mean Prediction Errors

  9. Results: Mean Prediction Errors

  10. Prediction Errors: Comparing the Formulas (p-values) Lower prediction error with SRK-T for both IOLs. Expect Haigis to improve with additional postop data input. Statistically significant difference in the spread of data between formulas only for Crystalens HD.

  11. Prediction Errors:Comparing the IOL Power Predictability Student’s t-Test: 0.004 ANOVA (F-test): 0.050

  12. Predictability using SRK-T

  13. Stability of Spherical Equivalent Refraction (D) *Only eyes with 1, 3, and 6 M data (16 eyes ReSTOR D1, 15 eyes Crystalens HD)

  14. Conclusions • SRK-T showed lower mean prediction error than Haigis for both IOLs • Mean Prediction Errors and variance were lower for the ReSTOR D1 IOL compared to the Crystalens HD, and the differences were statistically significant. • Predictability good with both IOLs (88% of ReSTOR and 77% of Crystalens eyes within 0.50 D of predicted spherical equivalent) Approaching the accuracy of LASIK? • Both IOLs showed excellent refractive stability to 6 months postoperatively • Further optimization of theoretical formulas should further improve predictability

  15. Conclusions Additional Study Needed: • Other IOL Calculation Formulas? • Impact of LRIs • Accounting for the gender discrepancy between groups • Predictability of Crystalens AO

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