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Prediction accuracy of the ORA intraoperative aberrometry device in the new Clareon® monofocal IOL

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First Author: L.Spekreijse THE NETHERLANDS

Co Author(s):    N. Bauer   F. van den Biggelaar   T. Berendschot   R. Nuijts           

Abstract Details

Purpose:

To evaluate refractive outcomes for the new Clareon® monofocal IOL in terms of achieved target refraction for the ORA® Intraoperative Wavefront Aberrometry device (Alcon Laboratories, Inc.) and preoperative noncontact biometry.

Setting:

University Eye Clinic Maastricht, Maastricht University Medical Center, the Netherlands. Surgeries were performed by 2 surgeons (RN and NB) who were experienced in using the ORA system.

Methods:

Patients with bilateral senile cataracts who underwent phacoemulsification in both eyes, either by delayed sequential surgery(2 weeks in-between) or on the same-day, were included in the study. Patients were excluded if they had an increased risk of refractive surprise (e.g.axial lengths <21mm or >27mm, previous refractive surgery). The implanted IOL power was based on noncontact optical biometry data (IOLmaster®700,Carl Zeiss Meditec AG) using the Barrett Universal II formula for IOL calculation (optimized for the Clareon® IOL). Postoperative subjective refraction was measured 4-6 weeks after surgery. Pre and post-OP refraction outcomes were analysed using the ORA AnalyzOR feature using non-optimized settings.

Results:

Eighty-two eyes (42 patients) were included in the study. Thirty-five patients underwent bilateral same-day surgery. Mean age (±SD) was 73±8 years and 36% of patients was male. For the ORA system, the percentage of eyes within 1.0D, 0.75D, 0.50D and 0.25D of target was 80.5%, 68.3%, 50.0% and 13.4%, respectively. For the preoperative biometry analysed by the Barrett Universal II formula these percentages were 96.3%, 86.6%, 74.4% and 47.6%, respectively. Mean absolute prediction error (±SD) was 0.62±0.37D for ORA and 0.35±0.28D for preoperative biometry (P<0.001).

Conclusions:

According to literature, a percentage of at least 90% of eyes that fall within 1.0D of target SE refraction is acceptable in current practice.[1]This study shows lower percentages of eyes within 1.0D,0.75D,0.50D and 0.25D for ORA compared to Barrett Universal II formula,when using the Clareon IOL. However, new IOLs require global and personal optimization, using postoperative refractive data,in order to achieve best possible outcomes. The current ORA results represent data prior to these optimization phases, in contrast to the results for the optimized Barrett formula. Further intraoperative measurements,postoperative measurements,and optimization should improve the ORA prediction for this IOL.

Financial Disclosure:

... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented