ROTATIONAL STABILITY OF 4 DIFFERENT ACRYLIC TORIC IOLS

Prospective comparative multicenter randomized open-label study to investigate the rotational stability of four different single piece acrylic toric IOLs.

15 clinical centers globally, three study arms

Three study arms compared the Hoya Vivinex Toric IOL to the Alcon Acrysof IQ Toric IOL (Arm 1, n = 93), J&J Tecnis Toric IOL (Arm 2 n = 96) and Zeiss AT Torbi 709 M IOL (Arm 3 n = 101). Primary endpoints were visual acuities, reduction of astigmatism and rotational stability. Exams were scheduled preop, at time of surgery (baseline), postop 1 day, 1 week, 1 month and 6 months. Rotational position was documented at all visits, acuities and subjective refraction at the last three visits. Multiple exams and tests were taken and will be described in detail @ time of presentation.

In Arm 1, mean absolute rotation angle was 1.5±1.2° (Hoya) and 1.2 ± 1.3° (Alcon). Hoya rotated >5° in 2.0%, Alcon 2.7%, none rotated >10°. In Arm 2, mean absolute rotation angle was 1.5±1.7° (Hoya) and 2.3±3.2° (J&J). Hoya rotated >5° in 4.4%, >10° 0%,  J&J >5° 10.0%, > 10° 5.0%. In Arm 3, mean absolute rotation angle was 1.2±1.1° (Hoya) vs. 2.7±3.3° (Zeiss). Hoya rotated >5° in 1.9%, >10° 0%,  Zeiss rotated >5° 7.0%, > 10° 4.7%. Sphere corrected visual acuity (SCVA) logMAR for Arm 1 was 0.01 ± 0.13 vs. 0.00 ± 0.10, Arm 2 –0.01 ± 0.12 vs. –0.02± .11, Arm 3 –0.01±0.11 vs. –0.01 ± 0.13 (Zeiss). Mean residual cylinder in Arm 1 was 0.39±0.45 D vs. 0.30±0 .37 D, Arm 2 0.46±0.34 D vs. 0.48±0.41 D, Arm 3 0.43±0.42 vs. 0.43±0.41.

As a trend, two of the examined IOL models (Hoya, Alcon) seemed more rotationally stable than the other two. No impact could be seen on SCVA or residual cylinder on average. No statistically significant differences could be proven. However, every single outlier in terms of rotation usually means a secondary surgical intervention and is to be avoided. One lens examined has been updated to improve rotational stability in the meantime.