Investigation of Multifocal Toric IOLs to Compensate for Corneal Astigmatism and to Provide Near, Intermediate, and Distance Vision José L. Rincón, MD Enrique Suárez, MD Libe Leizaola, MD Consultant, Alcon Laboratories, Inc. Alcon sponsored the study and provided statistical and presentation support.

Background Conventional monofocal intraocular lenses can leave many cataract patients with residual astigmatism and without the ability to focus on objects at near distances A recent innovation in cataract surgery consists of the introduction of toric intraocular lenses that can correct corneal astigmatism Multifocal toric intraocular lenses allow for the correction of near vision, as well as distance vision, and also preoperative corneal astigmatism

Purpose This study investigated the efficacy of a new apodized diffractive multifocal toric IOL in subjects with cataracts and corneal astigmatism

Subjects and Methods Study conducted at two clinical sites in Venezuela Adult subjects who presented for cataract surgery and/or refractive lens exchange requiring bilateral surgery were enrolled Subjects were required to have corneal astigmatism that was regular, bowtie-shaped, bilateral, and ≥0.75 to ≤2.5 D preoperatively

Subjects and Methods Subjects were considered eligible if they qualify for multifocal IOLs with the AcrySof online toric calculator Surgery was performed using small incisions (<3.0 mm) Limbal relaxing incisions were not performed

Subjects and Methods Assessment  1-Month follow up Manifest refraction Autokeratometry Patient satisfaction with vision without glasses was assessed using subjective questionnaire on a 0-10 point scale, where 0 = highly dissatisfied and 10 = completely satisfied Mean age of subjects: /- 7 yrs (N= 20) Incision Size: / mm (n = 39 eyes)

Results Mean spherical equivalent (n = 39 eyes) (n = 25 eyes) Diopter 0.61

Results Mean refractive astigmatism Significant reduction in astigmatism postoperatively – indicates effective treatment with ReSTOR toric IOL (p < ) (Mean + SD) (n = 39 eyes) (n = 25 eyes) (p < ) Diopter

Results Mean corneal astigmatism (autokeratometry) No significant difference in corneal astigmatism between preop and 1-month (Mean + SEM) (n = 39 eyes) (n = 25 eyes) Diopter

@ 1 mo post operation: 100% subjects reported never wearing eye glasses (n = 10) Overall Satisfaction with uncorrected vision was 8.83 ± 1.17 on a 0 to 10 point scale where 0 = highly dissatisfied and 10 = completely satisfied Results

Conclusion 1-month follow up interim results indicate that: Refractive astigmatism reduced significantly after IQ ReSTOR toric IOL implantation (p < ) without significant change in corneal astigmatism 100% subjects (n=10) report spectacle independence (not wearing eye glasses) after ReSTOR toric IOL implantation Overall satisfaction with uncorrected vision was high (a score of 8.8 out of max 10) with ReSTOR toric IOLs