Investigation of Multifocal Toric IOLs to Compensate for Corneal

Astigmatism and to Provide Near, Intermediate, and Distance Vision

José L. Rincón, MDEnrique Suárez,

MDLibe 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: 59.8 +/- 7 yrs (N= 20)

• Incision Size: 2.59 +/- 0.41 mm (n = 39 eyes)

ResultsMean spherical

equivalent

Preop 1-Month0.0

0.5

1.0

1.5

2.0

2.5

3.0

Chart Title

0.11

(n = 39 eyes) (n = 25 eyes)

Diop

ter

0.61

ResultsMean refractive astigmatism

Preop 1-Month0.0

0.4

0.8

1.2

1.6

2.0

Significant reduction in astigmatism postoperatively – indicates effective treatment with ReSTOR toric IOL (p < 0.0001)

(Mean + SD)

(n = 39 eyes) (n = 25 eyes)

(p < 0.0001)

Diop

ter

0.99 0.32

ResultsMean corneal astigmatism (autokeratometry)

No significant difference in corneal astigmatism between preop and 1-month

Preop 1-Month0.0

0.5

1.0

1.5

2.0

2.5

3.0 (Mean + SEM)

(n = 39 eyes) (n = 25 eyes)

Diop

ter

1.43 1.51

@ 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

Conclusion1-month follow up interim results indicate that: • Refractive astigmatism reduced

significantly after IQ ReSTOR toric IOL implantation (p < 0.0001) 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