USAMA MOURIS BEBAWY, MB MBChCLINICAL FELLOW, MCMASTER UNIVNo Financial Disclosure

GEORGE H.H. BEIKO, B.M.,B.Ch.,FRCSCST. CATHARINES, CANADAASSIST PROF, MCMASTER UNIVLECTURER, UNIV OF TORONTOConsultant to AMO

Patient Satisfaction and Visual Performance After Bilateral

Implantation of Multifocal IOLs: Prospective Study

TecnisTM Multifocal Multicentre Trial -

Evaluation Parameters • Goal to enroll 250 patients to be bilaterally implanted with the Tecnis Multifocal IOL, at 25 sites

• Method:• Pre and post-op patient qualitative questionnaires on

freedom from glasses at different distances, and on dysphotopic phenomenom

• Pre and post-op surgeon qualitative and quantitative questionnaires on refraction and uncorrected visual acuity for Far, Intermediate and Near distance

• Assessments at pre-op, one and six months post-op

Patient Selection Criteria• Male and female adult patients with presbyopia for which bilateral cataract surgery

or clear lensectomy and posterior chamber IOL implantation is indicated.

• Good candidate for multifocal vision, i.e. motivated, desires spectacle independence and understands the trade-off of improved near vision to possible unwanted visual sensations.

• Visual potential of 20/25 or better in each eye after cataract extraction and IOL implantation.

• Patient dissatisfaction with their uncorrected or best corrected vision such that they desire surgery.

• Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes.

• IOL power available for both eyes being treated

Patient Exclusion Criteria• Patients with history of prior refractive surgery.

• Patient has ocular or systemic disease, or ocular trauma that may confound the outcome; (e.g. uncontrolled diabetes mellitus, prior ocular surgery, recurrent inflammatory conditions, or macular degeneration).

• Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. severe pseudoexfoliation syndrome, Marfan’s syndrome).

• Pupil abnormalities that prevent pupil from dilating at least 3.5 mm under mesopic/scotopic conditions.

• Patients with forme fruste keratoconus or keratoconus.

• Patients with visually significant macula or retina disease

Preliminary Results as of Oct. 1, 2010

• # of surgeons participating in the trial: 15G Beiko BM, BCh, FRCS(C) M Boileau MD, FRCS(C) C Ferremi MD, FRCS(C) M M Gagnon, MD, FRCS(C) L Lalonde MD, FRCS(C) C Menard, MD, FRCS(C) T Nagy, MD, FRCS(C) C Perreault MD, FRCS(C) S Shaver MD, FRCS(C) S Somai MD, FRCS(C) R Swieca MD, FRCS(C) Z Tadrous, MD, FRCS(C) E Tam MD, FRCS(C) B Teboul MD, FRCS(C) D Yan MD, FRCS(C)

• # of patients having completed pre-op questionnaire:136

• # of patients having completed 1 month post-op follow-up: 78

• # of patients having completed 3 month post-op follow-up: 63

Patient Profile:Myopes Hyperopes

Number 60 76

Age (yrs) 61.67 +/- 8.84 66.84 +/- 9.48

% Female 61.67 64.47

Photopic Pupil 3.83 +/- 1.35 3.52 +/- 1.03

Mesopic Pupil 3.99 +/- 1.43 3.65 +/- 1.10

Pre-op Refraction (D) -4.30 +/- 2.97 +2.04 +/- 1.54

Target Refraction (D) +0.09 +/- 0.11 +0.18 +/- 0.17

Results: Myopes Hyperopes

Target Refraction (D) +0.09 +/- 0.11 +0.18 +/- 0.17

Achieved Refraction (D) 1 month 0.48 +/- 0.44 0.40 +/- 0.29

Achieved Refraction (D) 3 month 0.45 +/- 0.37 0.27 +/- 0.25

Vision, Both Eyes,Distance, Best Corrected:

Vision, Both Eyes,Intermediate, Best Distance

Corrected:

Vision, Both Eyes,Near, Best Distance Corrected:

Patient Reading Distance Comfort:

Very Comfortable Very Uncomfortable

Spectacle Independence:

Almost Always Never

• Post-op target refraction was achieved and stable to 3 month visit

• Hyperopic patients tend to have better uncorrected and distance corrected VA for distance, intermediate and near

• Hyperopic patients have more comfortable reading vision and greater spectacle independence

Canadian TecnisTM Multifocal Multicentre

Trial