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Ling Lin, Srividhya Vilupuru; Evaluation of Centration and Its Effect on Visual Outcomes in Small-aperture IOL Patients. Invest. Ophthalmol. Vis. Sci. 2017;58(8):1146.
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Small-aperture intraocular lens and small-aperture corneal inlay (IC-8 IOL and KAMRA inlay, AcuFocus Inc., Irvine, CA) improve near vision in presbyopic patients by extending depth of focus via an optically similar small-aperture mask. The mask in IC-8 IOL (IC-8) is embedded in a colorless, hydrophobic acrylic, aspheric IOL. AcuTarget HD diagnostic instrument (ATHD, Visiometrics, Spain) which has been used to accurately measure centration of KAMRA inlay is applied to measure centration of IC-8. The purpose of this study was to evaluate ATHD measurement of IC-8 postoperative centration and its effect on visual performances.
In a post-market clinical evaluation, 114 patients were contralaterally implanted with IC-8 in one eye and a monofocal IOL in the other eye, and 9 patients were implanted with IC-8 bilaterally. Centration of IC-8 was measured with respect to the first Purkinje image (P1) and the pupil center (PC) by ATHD in a subgroup at one or multiple visits. Mean centration was calculated with averaged data across all visits (n = 49 and 18 for IC-8 position vs. P1 and PC, respectively). Correlation between centration and best-corrected distance visual acuity (BCDVA), subjective visual symptoms and satisfaction was calculated with pooled data from individual visits (n = 89 and 30 for IC-8 position vs. P1 and PC, respectively).
The mean ± SD (min, max) of average IC-8 position vs. P1 and PC were 230.1 ± 125.9 (43, 575) µm and 159.0 ± 132.6 (42, 496) µm, respectively. The mean ± SD (min, max) of change in IC-8 position vs. P1 and PC between visits were 96.1 ± 90.3 (5, 389) µm and 145.8 ± 98.7 (12, 334) µm, respectively. Linear regression showed no correlation between BCDVA and IC-8 position vs. P1 (R2 = 0.02, F(1, 87) = 1.39, p = 0.2423) or vs. PC (R2 = 0.05, F(1, 28) = 1.55, p = 0.2234). There were ten IC-8 position measurements over 400 µm vs. P1 and five measurements over 300 µm vs. PC; their corresponding BCDVA were all 20/25 or better. Similarly, no correlation was found between centration and subjective visual symptoms or satisfaction.
The variation observed in IC-8 centration results could be from several sources including small amounts of potential postoperative movement of IOL and the centration measurement. Taking that into consideration, current results showed no effect of centration on visual or subjective outcomes in IC-8 implanted patients.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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