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Refractive Lens Surgery

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62 S. Bylsma<br />

length),underwent full FDA clinical trial,leading<br />

to its approval in 1998. Data from the overall<br />

FDA study showed 76% of cases within 10<br />

degrees, 88% within 20 degrees, and 95%<br />

within 30 degrees of the intended cylindrical<br />

axis. The uncorrected visual acuity (UCVA) of<br />

eyes with the STIOL was significantly improved<br />

compared to those that received the<br />

spherical IOL of similar design. Two years later,<br />

the FDA went on to designate the STIOL as<br />

a “new-technology” IOL due to its demonstrated<br />

improvement of UCVA in astigmatic<br />

patients when compared to a spherical IOL.<br />

Thereafter, the longer TL model was introduced<br />

in the lower diopter powers (£24 D) as<br />

a prophylactic against off-axis rotations in<br />

these larger myopic eyes. To date, both STIOL<br />

models have been widely evaluated [34–41].<br />

These reports are quite consistent in demonstrating<br />

a predictable improvement in UCVA<br />

with the STIOL,yet they do differ widely in the<br />

occurrence of early off-axis rotation.<br />

In 2000, Sun and colleagues [35, 36] retrospectively<br />

compared 130 eyes that received<br />

the Staar AA-4203-TF to 51 eyes that received<br />

a spherical IOL with LRI. The STIOL was<br />

found to be superior to LRIs in producing<br />

UCVA of ≥20/40 (84% vs. 76%) as well as in<br />

reducing refractive cylinder to £0.75 D (55%<br />

vs. 22%) and to £1.25 D (85% vs. 49%).<br />

Twelve eyes (9%) underwent STIOL repositioning<br />

for off-axis rotation. That same year,<br />

Ruhswurm used only the +2.0-D toric power<br />

STIOL in 37 eyes with a mean preoperative<br />

refractive cylinder of 2.7 D and found 48% to<br />

achieve UCVA of 20/40 or better, with a reduction<br />

of refractive cylinder to 0.84 D postoperatively<br />

[37]. No cases of STIOL rotation<br />

greater than 30 degrees were observed, although<br />

19% rotated up to 25 degrees.<br />

One year later, Leyland’s group used vector<br />

analysis software to calculate the magnitude<br />

of expected correction produced by the STI-<br />

OL in 22 eyes [38]. The group achieved 73%<br />

of the planned reduction of astigmatism, including<br />

the 18% of cases that experienced<br />

off-axis rotation by more than 30 degrees. In<br />

a smaller study of four eyes, a digital overlay<br />

technique was used to measure precisely the<br />

STIOL axis postoperatively; 75% of eyes were<br />

determined to be within 5 degrees and clinical<br />

slit-lamp estimates of axis were found to<br />

be quite precise in all cases [39]. All these reports<br />

exclusively studied the shorter TF model,<br />

as it was the only design available to the<br />

investigators at the time of their studies.<br />

More recent studies include data on the<br />

longer TL model. Till reported on 100 eyes and<br />

found a magnitude of reduction of 1.62 D for<br />

the +2.0-D toric power and 2.86 D for the +3.5-<br />

D power in the 89% of eyes that were observed<br />

to be within 15 degrees of the intended axis<br />

[40]. No difference in rotation rate between<br />

STIOL models was observed. In contrast,<br />

Chang compared the 50 cases receiving the<br />

longer TL model against the 11 receiving the<br />

shorter TF model and found a significant difference<br />

in rotation rates specifically for the TF<br />

group in the lower diopter range [41]. No case<br />

of rotation of more than 10 degrees was observed<br />

in any of the 50 eyes with the TL or in<br />

the five eyes with the higher-power TF.However,<br />

three of six eyes with the lower-power TF<br />

model required repositioning. This strongly<br />

suggests that lengthening the original (short)<br />

TF model in the lower power range (£24 D)<br />

may prove to be very beneficial in discouraging<br />

early off-axis rotations of the STIOL.<br />

In summary, the STIOL has been widely<br />

studied, with the reports showing a consistent,<br />

predictable effect of reduction of preoperative<br />

refractive cylinder for the group of<br />

eyes studied. The variability in the magnitude<br />

of correction of the STIOL in these numerous<br />

studies is not surprising, as the amount of<br />

refractive (spectacle) astigmatism correction<br />

of a given IOL varies with the overall refractive<br />

error of each patient [42]; myopes will<br />

achieve greater spectacle correction of astigmatism<br />

than hyperopes due to vertex-distance<br />

issues. Regardless, the STIOL has been<br />

clearly shown to be highly predictable in the<br />

correction of astigmatism at the time of refractive<br />

lens surgery.

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