1. Clinical Outcomes Post AcrySof Toric IOL Implantation In 231 Consecutive Eyes Johnny L. Gayton, MD, FSEE Eyesight Associates 216 Corder Road 216 Corder Road Warner Robins, Georgia 31088 Johnny L. Gayton, MD, FSEE Eyesight Associates 216 Corder Road 216 Corder Road Warner Robins, Georgia 31088 The author is on the speaker’s bureau for Alcon Laboratories, Inc.

2. 2 Purpose To compare visual outcomes of good candidates versus complex candidates after implantation of AcrySof Toric intraocular lenses (IOLs) in a large consecutive series of cataractous, astigmatic eyes To isolate variables of interest, many AcrySof Toric studies 1-3 excluded patients with –comorbid ocular conditions, including complications relating to the retina, to the cornea, or to ocular pressure –a high degree of corneal astigmatism that would require additional limbal relaxing incisions (LRIs) Real-world patients can be complex To compare visual outcomes of good candidates versus complex candidates after implantation of AcrySof Toric intraocular lenses (IOLs) in a large consecutive series of cataractous, astigmatic eyes To isolate variables of interest, many AcrySof Toric studies 1-3 excluded patients with –comorbid ocular conditions, including complications relating to the retina, to the cornea, or to ocular pressure –a high degree of corneal astigmatism that would require additional limbal relaxing incisions (LRIs) Real-world patients can be complex 1. AcrySof Toric Product Information. Fort Worth, TX: Alcon Laboratories, Inc., 2005. 2. Mendicute J, et al. J Cataract Refract Surg 2008;34:601-607. 3. Zuberbuhler B, et al. BMC Ophthalmol 2008;8:8.

3. 3 Methods: Consecutive Patient Enrollment Prospectively enrolled 162 adults (231 eyes) with cataracts and regular corneal astigmatism (≥0.5 D with the rule or ≥1.0 D against the rule) Patients categorized by ocular complexities (solid lines) and/or surgeries scheduled concurrently with IOL implantation (dashed lines) Prospectively enrolled 162 adults (231 eyes) with cataracts and regular corneal astigmatism (≥0.5 D with the rule or ≥1.0 D against the rule) Patients categorized by ocular complexities (solid lines) and/or surgeries scheduled concurrently with IOL implantation (dashed lines) All eyes (n = 231) Good candidates (n = 121) Complex candidates (n = 110) Retinal/ macular (n = 48) Dry eye (n = 9) Angle/ pressure (n = 23) Corneal (n = 10) Extra- ocular (n = 11) Cataract- related (n = 12) Other (n = 2) LRI with IOL (n = 13) Any previous (n = 13) Endolaser (n = 6) Punctal cautery (n = 1) Lateral rectus recession (n = 1) +Kenalog (n = 2) Ocular surgery (n = 26) Most prevalent complexities were angle/pressure, retinal/macular, and LRI with IOL. Angle/pressure complexities included open-angle glaucoma, narrow-angle glaucoma, ocular hypertension, narrow angles. Retinal/macular complexities included age-related macular degeneration, macular drusen, other macular changes.

4. 4 Methods: Lens Model Selection & LRI Inclusion Each patient’s measurements entered into the AcrySof Toric Calculator (www.acrysoftoriccalculator.com) to determine lens model –All incisions temporal –Surgically induced astigmatism = 0.3 D For against-the-rule astigmatism (steep axis within 30º of horizontal) –1.0 D to 2.75 D, toric lens only –≥2.75 D, toric lens + LRIs For with-the-rule astigmatism (steep axis within 30º of vertical) –0.5 D to 2.25 D, toric lens only –≥2.25 D, toric lens + LRIs Each patient’s measurements entered into the AcrySof Toric Calculator (www.acrysoftoriccalculator.com) to determine lens model –All incisions temporal –Surgically induced astigmatism = 0.3 D For against-the-rule astigmatism (steep axis within 30º of horizontal) –1.0 D to 2.75 D, toric lens only –≥2.75 D, toric lens + LRIs For with-the-rule astigmatism (steep axis within 30º of vertical) –0.5 D to 2.25 D, toric lens only –≥2.25 D, toric lens + LRIs Model Cylinder power, D 1 Corneal astigmatism correction ranges, D at IOL planeat corneal plane SN60T3, or “T3”1.501.030.90 – 1.50 SN60T4, or “T4”2.251.551.50 – 2.00 SN60T5, or “T5”3.002.062.00 – 2.50 1. AcrySof Toric Product Information. Fort Worth, TX: Alcon Laboratories, Inc., 2005.

5. 5 Methods: Surgical Procedures With patient sitting up, eye marked at 0º & 180º Self-sealing 2.2-mm temporal incision Viscoelastic injected –DuoVisc, standard and Fuchs cases –DisCoVisc, floppy iris & endolaser cases Continuous curvilinear capsulorhexis Second entry with 15º slit blade Nucleus removed using cracking, chopping, hydrodissection Axis marks placed on the eye IOL injected & aligned I. gross alignment – while IOL was unfolding (see figure) II. stabilization – during OVD removal, preventing IOL rotation III. fine alignment – rotated clockwise onto final intended axis With patient sitting up, eye marked at 0º & 180º Self-sealing 2.2-mm temporal incision Viscoelastic injected –DuoVisc, standard and Fuchs cases –DisCoVisc, floppy iris & endolaser cases Continuous curvilinear capsulorhexis Second entry with 15º slit blade Nucleus removed using cracking, chopping, hydrodissection Axis marks placed on the eye IOL injected & aligned I. gross alignment – while IOL was unfolding (see figure) II. stabilization – during OVD removal, preventing IOL rotation III. fine alignment – rotated clockwise onto final intended axis

6. 6 Methods: Scheduling and Assessment Assessment at intake –Snellen acuity at 4 m: uncorrected (UCDVA) and best-corrected (BCDVA) –IOLMaster –Manual keratometry First eye surgery within 30 days of preoperative assessment; fellow eye surgery ≥7 days after the first operation (when applicable) Follow-up assessment at ~6 weeks (average 44 ± 39 days) postoperatively –Snellen acuity at 4 m: UCDVA and BCDVA –Capsular haze assessment Assessment at intake –Snellen acuity at 4 m: uncorrected (UCDVA) and best-corrected (BCDVA) –IOLMaster –Manual keratometry First eye surgery within 30 days of preoperative assessment; fellow eye surgery ≥7 days after the first operation (when applicable) Follow-up assessment at ~6 weeks (average 44 ± 39 days) postoperatively –Snellen acuity at 4 m: UCDVA and BCDVA –Capsular haze assessment

7. 7 Results: Astigmatism and Its Correction All eyes Good candidates Complex candidates Complex candidate subgroups LRI with IOLAngle/pressureRetinal/macular Eyes231 121110132348 Preop astigmatism With the rule Oblique Against the rule 37% 7% 56% 41% 4% 55% 32% 10% 58% 62% 0% 38% 50% 5% 45% 22% 9% 70% Magnitude, D1.9 ± 1.01.7 ± 0.72.1 ± 1.2*3.9 ± 1.2* 1.9 ± 0.81.9 ± 1.2 IOL model T3 T4 T5 45% 29% 26% 52% 30% 18% 38% 27% 35% -- 100% 23% 45% 32% 52% 28% 20% Postop astigmatism, D0.4 ± 0.60.3 ± 0.40.5 ± 0.8*1.5 ± 1.7*0.3 ± 0.50.4 ± 0.5 Astigmatism reduced79%84%75%61%*84%79% Toric lens generally effective at reducing astigmatism in all eye groups Residual cylinder was larger and more variable in highly astigmatic eyes where adjunctive LRIs were needed *P < 0.05 versus good candidates

8. 8 Results: Residual Astigmatism by Model Residual cylinder varied significantly by model –0.24 ± 0.06 diopters for the T3 lens –0.32 ± 0.07 diopters for the T4 lens –0.71 ± 0.08 diopters for the T5 lens 1.5 ± 1.7 D for eyes with adjunctive LRIs 0.5 ± 0.4 D for eyes without LRIs Residual cylinder varied significantly by model –0.24 ± 0.06 diopters for the T3 lens –0.32 ± 0.07 diopters for the T4 lens –0.71 ± 0.08 diopters for the T5 lens 1.5 ± 1.7 D for eyes with adjunctive LRIs 0.5 ± 0.4 D for eyes without LRIs

9. 9 Uncorrected (UCDVA) and best-corrected (BCDVA) BCDVA preop and postop worse in retinal/macular group; contributed to poorer values in complex group overall Postoperative BCDVA and UCDVA worse in LRI group; contributed to poorer values in complex group overall Uncorrected (UCDVA) and best-corrected (BCDVA) BCDVA preop and postop worse in retinal/macular group; contributed to poorer values in complex group overall Postoperative BCDVA and UCDVA worse in LRI group; contributed to poorer values in complex group overall Results: Average Distance Visual Acuity Preoperative *P < 0.05 versus good candidates Postoperative all good complex LRI angle/ pressure retinal/ macular eye candidate type visual acuity, decimal 0123 * * * * * 20/20 -0.50.00.51.01.5 eye candidate type visual acuity, decimal * * 20/20 all good complex LRI angle/ pressure retinal/ macular

10. 10 Results: Percent of Eyes at 20/20 or 20/40 Snellen visual outcomes: 20/20 or better 20/40 or better UCDVA of 20/20 or better attained by lower proportions of complex candidates (15%) than good candidates (26%) UCDVA of 20/40 or better attained by high proportions of all eye types –81% of good candidates, 75% of complex candidates (not statistically different) –70% of eyes with LRIs, P = 0.02 versus good candidates Snellen visual outcomes: 20/20 or better 20/40 or better UCDVA of 20/20 or better attained by lower proportions of complex candidates (15%) than good candidates (26%) UCDVA of 20/40 or better attained by high proportions of all eye types –81% of good candidates, 75% of complex candidates (not statistically different) –70% of eyes with LRIs, P = 0.02 versus good candidates 0%20%40%60%80%100% all good complex LRI angle/ pressure retinal/ macular Eye candidate type Eyes at visual acuity level 0%20%40%60%80%100% Eyes at visual acuity level all good complex LRI angle/ pressure retinal/ macular Eye candidate type Uncorrected Best-corrected * * *P < 0.05 versus good candidates * * *

11. 11 Results: Capsular Haze Capsular haze was observed in 14% of eyes –haze tended to be trace (9% of eyes) or mild (3% of eyes) –2% had moderate or dense haze, or haze cleared by laser capsulotomy Capsular haze equally likely in good or complex eyes –moderate, dense, capsulotomy cases more common in complex candidates (P = 0.01) Capsular haze was observed in 14% of eyes –haze tended to be trace (9% of eyes) or mild (3% of eyes) –2% had moderate or dense haze, or haze cleared by laser capsulotomy Capsular haze equally likely in good or complex eyes –moderate, dense, capsulotomy cases more common in complex candidates (P = 0.01)

12. 12 Conclusions AcrySof Toric IOLs can provide good UCDVA (20/40 or better) to a majority of patients with astigmatic, cataractous eyes  even in complex cases Adding adjunctive LRIs in cases of high astigmatism can yield less predictable and suboptimal outcomes  adjunctive LRIs on a high-cylinder eye are not as straightforward as LRIs on a lower-cylinder eye  an AcrySof IOL model with stronger cylinder power would be useful AcrySof Toric IOLs can provide good UCDVA (20/40 or better) to a majority of patients with astigmatic, cataractous eyes  even in complex cases Adding adjunctive LRIs in cases of high astigmatism can yield less predictable and suboptimal outcomes  adjunctive LRIs on a high-cylinder eye are not as straightforward as LRIs on a lower-cylinder eye  an AcrySof IOL model with stronger cylinder power would be useful