Refractive Lens Surgery
Refractive Lens Surgery
Refractive Lens Surgery
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tion to benefiting from less exposure of the<br />
retina to blue light, color perception should<br />
seem more natural to these patients as opposed<br />
to the increased blueness, clinically<br />
known as cyanopsia, reported by patients<br />
who have received colorless UV-blocking<br />
IOLs [38].<br />
16.6 FDA Clinical Study<br />
In order to gain approval of the Food and<br />
Drug Administration (FDA), a multi-centered,<br />
randomized prospective study was<br />
conducted in the USA. It involved 300 patients<br />
randomized to bilateral implantation<br />
of either the AcrySof Natural IOL or the clear<br />
AcrySof Single-Piece IOL. One hundred and<br />
fifty patients received the AcrySof Natural<br />
IOL and 147 patients received the AcrySof<br />
Chapter 16 Blue-Light-Filtering Intraocular <strong>Lens</strong>es 155<br />
Fig. 16.4. Data from Alcon’s FDA study showing no significant difference in best corrected visual acuity<br />
between the AcrySof colorless IOL and the AcrySof Natural IOL<br />
Single-Piece IOL as a control. Patients with<br />
bilateral age-related cataracts who were willing<br />
and able to wait at least 30 days between<br />
cataract procedures and had verified normal<br />
preoperative color vision were eligible for the<br />
study. In all bilateral lens implantation cases,<br />
the same model lens was used in each eye.<br />
Postoperative parameters measured included<br />
visual acuity, photopic and mesopic contrast<br />
sensitivity, and color perception using the<br />
Farnsworth D-15 test. Results showed that<br />
there was no difference between the AcrySof<br />
Natural IOL and the clear AcrySof IOL in<br />
any of these parameters [39] (Figs. 16.4, 16.5,<br />
16.6 and 16.7). More substantial color perception<br />
testing using the Farnsworth–Munsell<br />
100 Hue Test has also demonstrated no<br />
difference in color perception between the<br />
AcrySof Natural IOL and the clear AcrySof<br />
IOL [39].