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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].

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