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Prospective Comparison of Visual Acuity and Corneal Cylinder After Implantation of Aspheric Toric IOL and Aspheric IOL With Limbal Relaxing Incisions. N. Timothy Peters, MD Clear Advantage Vision Center, Portsmouth, NH Anna F. Fakadej, MD Carolina Eye Associates, Southern Pines, NC.
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Prospective Comparison ofVisual Acuity and Corneal CylinderAfter Implantation of Aspheric Toric IOL andAspheric IOL With Limbal Relaxing Incisions N. Timothy Peters, MD Clear Advantage Vision Center, Portsmouth, NH Anna F. Fakadej, MD Carolina Eye Associates, Southern Pines, NC Alcon funded this study and assisted with the preparation of this ePoster.
Study Purpose & Eligible Patients • Purpose: This study was designed to evaluate postoperative visual acuity and cylinder outcomes of cataract patients who received contralateral implantation of • aspheric toric IOLs in one eye, versus • aspheric IOLs plus limbal relaxing incisions (LRIs) in the other eye • Eligibility: Three investigators enrolled adults (≥21 years old) with bilateral cataracts and bilateral corneal astigmatism that • was regular (bow-tie shaped) • was qualified for the AcrySof® IQ Toric IOL (Alcon) according to www.AcrySofToricCalculator.com • had a preoperative magnitude of ≥0.75 D
Study Design • Randomization: • For each patient, the first eye was randomized to either • an aspheric toric IOL (model SN6AT3, SN6AT4, or SN6AT5, as appropriate), or • an aspheric nontoric IOL (model SN60WF) paired with LRIs. • The second eye received the opposite treatment within 1 month. • Masking: Subjects were masked to the treatment type of each eye,though investigators could not be masked.
Surgical Techniques • Primary incisions (for phacoemulsification and IOL insertion) were placed on the steep axis or on the surgeon’s preferred operating axis. • Limbal relaxing incisions were fashioned according to the routine standard of care at each site; nomograms differed slightly between surgeons, but all nomograms included the following considerations: • Tailored for with-the-rule versus against-the-rule astigmatism • Tailored for age of patient in 10-year intervals • Tailored for thickness of cornea (by pachymetry), to reach 90% of corneal depth
Baseline and Follow Up • At baseline, 70 patients were enrolled: • Mean age was 67.0 ± 11.5 years (range, 32 to 92) • 31% were men (22 of 70) and 69% were women (48 of 70) • Monocular corrected distance visual acuity (CDVA) and corneal cylinder were statistically similar between randomization groups: • Follow up data were available for 63 patients at 1 month postoperative and 60 patients at 3 months postoperative †Not all data were available for all eyes at the time of this analysis.
Corrected Distance Visual Acuity (CDVA) CDVA was statistically significantly better in the aspheric toric IOL group than in the aspheric IOL + LRI group at 1 month and 3 months postoperative: The magnitude of difference between groups was approximatelyhalf of a Snellen line at 3 months postoperative. Preoperative Aspheric Toric IOL -0.03 ± 0.09 logMAR 0.02 ± 0.12 logMAR Aspheric IOL + LRIs ↑ *P = 0.002between groups ↑ *P = 0.01between groups Error bars represent standard deviation.
Uncorrected Distance Visual Acuity (UDVA) • Preoperative UDVA values were not available for most patients because of extremely poor vision without correction. • Postoperative UDVA was significantly better in the aspheric toric IOL group than in the aspheric IOL + LRI group at 1 and 3 months: • The magnitude of difference between groups was approximatelyhalf of a Snellen line at both postoperative time points. 0.08 ± 0.13 0.08 ± 0.12 0.13 ± 0.16 0.14 ± 0.17 UDVA, Snellen *P = 0.02 *P = 0.001 Error bars represent standard deviation and are shown unidirectional for clarity.
Residual Refractive Astigmatism after 3 Months • More eyes had larger amounts of residual astigmatism following astigmatism correction with aspheric IOLs + LRIs than with aspheric toric IOLs. 52 of 60 43 of 60 11 of 60 7 of 60 6 of 60 †1.7% = 1 of 60
Discussion and Conclusions • In this randomized, prospective, controlled study of aspheric toric IOLs versus contralateral aspheric IOLs + LRIs, 3-month postoperative outcomes indicated that • Corrected distance visual acuity was significantly better (P = 0.002) withaspheric toric IOLs than with aspheric IOLs + LRIs • Uncorrected distance visual acuity was significantly better (P = 0.001) withaspheric toric IOLs than with aspheric IOLs + LRIs • Residual astigmatism was lower in more eyes withaspheric toric IOLs than with aspheric IOLs + LRIs • The study is still ongoing; forthcoming results will include longer-term outcomes (to 6 months postoperative).