Objective: Potential risk factors and visual performance measures were evaluated for relationship to self-report of clinical visual symptoms after the refractive procedure for placement of Intacs microthin prescription inserts for myopia. Design: Retrospective nonrandomized comparative study. Participants/Intervention: Patients were participants in the U.S. Food and Drug Administration phase III KeraVision prospective clinical trials. Main Outcome Measures: Study participants (n = 263) were retrospectively classified into one of three outcome groups on the basis of postoperative self-reported visual symptoms and/or request for Intacs inserts removal through month 24. Differences between outcome groups in visual acuity, refractive error, corneal geometry, corneal topography, type of preoperative corrective lens wear, and demographic variables were evaluated with multivariate logistic regression. Results: Clinical trial participants who had preoperative mean keratometry >45 diopters (D) (adjusted odds ratio [OR], 0.43; 95% confidence interval [Cl], 0.21, 0.85, P = 0.02), manifest refractive astigmatism of 0.75 D or 1.00 D (adjusted OR, 0.52; 95% Cl, 0.25, 1.08, P = 0.08), measured uncorrected visual acuity ≥2 lines better than that predicted by their respective cycloplegic refractive error (adjusted OR, 0.39; 95% Cl, 0.14, 1.12, P = 0.08) and/or had worn soft contact lenses (adjusted OR, 0.58; 95% Cl, 0.32, 1.04, P = 0.07) tended to be less likely to report postoperative clinical visual symptoms with Intacs inserts. Risk of clinical visual symptoms and request for Intacs inserts removal approximately doubled for each 0.50 D of additional postoperative defocus equivalent (crude OR, 1.86; 95% Cl, 1.39, 2.48, P = 0.00). Controlling for postoperative defocus and important preoperative risk factors, subjects who reported significant clinical visual symptoms were more likely to have had preoperative uncorrected visual acuity that was worse than that predicted by their respective cycloplegic refractive error (adjusted OR, 1.84; 95% Cl, 0.98, 3.42, P = 0.06). Risk of reporting clinical visual symptoms was increased with mesopic pupil diameter ≥6.5 mm (adjusted OR, 1.76; 95% Cl, 0.96, 3.24, P = 0.07). Within the group of patients who reported postoperative clinical visual symptoms, 71 of 122 (58%) had ceased reporting them by month 24. Conclusions: Adjusting for important risk factors simultaneously, this study suggested that certain preoperative characteristics may increase or decrease the likelihood, depending on the characteristic, of refractive surgery candidates to report significant clinical visual symptoms with Intacs inserts.
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