IMPORTANCE: Spectacle independence is becoming increasingly important in cataract surgery. Not correcting corneal astigmatism at the time of cataract surgery will fail to achieve spectacle independency in 20% to 30% of patients. OBJECTIVE: To compare bilateral aspherical toric with bilateral aspherical control intraocular lens (IOL) implantation in patients with cataract and corneal astigmatism. DESIGN, SETTING, AND PARTICIPANTS: A multicenter, hospital-based, randomized clinical trial was conducted. The participants included 86 individuals with bilateral cataract and bilateral corneal astigmatism of at least 1.25 diopters (D) who were randomized to receive either bilateral toric (n = 41) or bilateral control (n = 45) IOL implantation. INTERVENTIONS:Bilateral implantation of an aspherical toric IOL or an aspherical control IOL. MAIN OUTCOMES AND MEASURES: Spectacle independency for distance vision, uncorrected distance visual acuity, refractive astigmatism, contrast sensitivity, wavefront aberrations, and refractive error-related quality-of-life questionnaire. RESULTS: Preoperatively, mean (SD) corneal astigmatism was 2.02 (0.95) D and 2.00 (0.84) D in the toric and control groups, respectively. Four patients (5%) were lost to follow-up. At 6 months postoperatively, 26 (70%) of the patients in the toric group achieved an uncorrected distance visual acuity of 20/25 or better compared with 14 (31%) in the control group (P < .001; odds ratio, 5.23; 95% CI, 2.03-13.48). Spectacle independency for distance vision was achieved in 31 patients (84%) in the toric group compared with 14 patients (31%) in the control group (P < .001; odds ratio, 11.44; 95% CI, 3.89- 33.63). Mean refractive astigmatism was -0.77 (0.52) D and -1.89 D (1.00) D, respectively. Vector analysis of toric IOLs showed a mean magnitude of error of +0.38 D, indicative of overcorrection. No significant differences were found in contrast sensitivity, higher-order aberrations, or refractive error-related quality of life. CONCLUSIONS AND RELEVANCE: In patients with cataract and corneal astigmatism, bilateral toric IOL implantation results in a higher spectacle independency for distance vision compared with bilateral control IOL implantation. No significant differences were identified in contrast sensitivity, higher-order aberrations, or refractive error-related quality of life following both treatments. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01075542.
RCT Entities:
IMPORTANCE: Spectacle independence is becoming increasingly important in cataract surgery. Not correcting corneal astigmatism at the time of cataract surgery will fail to achieve spectacle independency in 20% to 30% of patients. OBJECTIVE: To compare bilateral aspherical toric with bilateral aspherical control intraocular lens (IOL) implantation in patients with cataract and corneal astigmatism. DESIGN, SETTING, AND PARTICIPANTS: A multicenter, hospital-based, randomized clinical trial was conducted. The participants included 86 individuals with bilateral cataract and bilateral corneal astigmatism of at least 1.25 diopters (D) who were randomized to receive either bilateral toric (n = 41) or bilateral control (n = 45) IOL implantation. INTERVENTIONS: Bilateral implantation of an aspherical toric IOL or an aspherical control IOL. MAIN OUTCOMES AND MEASURES: Spectacle independency for distance vision, uncorrected distance visual acuity, refractive astigmatism, contrast sensitivity, wavefront aberrations, and refractive error-related quality-of-life questionnaire. RESULTS: Preoperatively, mean (SD) corneal astigmatism was 2.02 (0.95) D and 2.00 (0.84) D in the toric and control groups, respectively. Four patients (5%) were lost to follow-up. At 6 months postoperatively, 26 (70%) of the patients in the toric group achieved an uncorrected distance visual acuity of 20/25 or better compared with 14 (31%) in the control group (P < .001; odds ratio, 5.23; 95% CI, 2.03-13.48). Spectacle independency for distance vision was achieved in 31 patients (84%) in the toric group compared with 14 patients (31%) in the control group (P < .001; odds ratio, 11.44; 95% CI, 3.89- 33.63). Mean refractive astigmatism was -0.77 (0.52) D and -1.89 D (1.00) D, respectively. Vector analysis of toric IOLs showed a mean magnitude of error of +0.38 D, indicative of overcorrection. No significant differences were found in contrast sensitivity, higher-order aberrations, or refractive error-related quality of life. CONCLUSIONS AND RELEVANCE: In patients with cataract and corneal astigmatism, bilateral toric IOL implantation results in a higher spectacle independency for distance vision compared with bilateral control IOL implantation. No significant differences were identified in contrast sensitivity, higher-order aberrations, or refractive error-related quality of life following both treatments. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01075542.