Journal of cataract and refractive surgery · 2015
Safety and effectiveness of a new toric presbyopia-correcting posterior chamber silicone intraocular lens.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Pepose Jay S, Hayashida Jon, Hovanesian John, Davies James, Labor Phillips Kirk, Whitman Jeffrey, Carter Harvey, Colvard Michael, Buckhurst Phillip J, Khodai Omid, Mittleman David, Feinerman Gregg
Аннотация
PURPOSE: To evaluate the safety and effectiveness of the Trulign toric intraocular lens (IOL) in adults with cataract.
SETTING: Eight private practices in the United States and 1 in Canada.
DESIGN: Prospective randomized single-masked multicenter study.
METHODS: A toric IOL (1.25 D, 2.00 D, or 2.75 D, determined by a toric calculator) was implanted in eligible patients with age-related cataract requiring a 16.00 to 27.00 diopter (D) spherical IOL power and with a predicted postoperative astigmatism of 0.83 to 2.50 D. Eyes within the lowest cylinder range (predicted postoperative astigmatism 0.83 to 1.32 D) were randomized in a 1:1 ratio between the 1.25 D toric IOL group and the nontoric accommodating IOL (Crystalens) control group.
RESULTS: The toric 1.25 D group had a statistically significantly greater percentage reduction in absolute cylinder (P < .001) and uncorrected distance visual acuity (P = .002) than the control group at the 120- to 180-day visit. The mean monocular uncorrected vision at distance, intermediate, and near was 20/25, 20/22, and 20/39, respectively, with the 1.25 D, 2.00 D, and 2.75 D toric IOLs in aggregate (toric group). In addition, 96.1% of patients (123/128) had 5.0 degrees or less absolute IOL rotation postoperatively. Regarding safety, the endpoints for preservation of corrected visual acuity and the incidence of complications and adverse events were met.
CONCLUSION: The toric IOL was safe and effective in reducing the effects of preoperative corneal astigmatism and provided excellent uncorrected distance and intermediate vision and functional near vision.
FINANCIAL DISCLOSURES: Dr. Pepose is a consultant to Bausch & Lomb and was medical monitor of this study. Drs. Buckhurst, Whitman, Feinerman, Hovanesian, Davies, Labor, and Carter are consultants to Bausch & Lomb. At the time of the study, Drs. Hayashida, and Khodai were employees of Bausch & Lomb. Drs. Colvard and Mittleman have financial or proprietary interest in any material or method mentioned.
SETTING: Eight private practices in the United States and 1 in Canada.
DESIGN: Prospective randomized single-masked multicenter study.
METHODS: A toric IOL (1.25 D, 2.00 D, or 2.75 D, determined by a toric calculator) was implanted in eligible patients with age-related cataract requiring a 16.00 to 27.00 diopter (D) spherical IOL power and with a predicted postoperative astigmatism of 0.83 to 2.50 D. Eyes within the lowest cylinder range (predicted postoperative astigmatism 0.83 to 1.32 D) were randomized in a 1:1 ratio between the 1.25 D toric IOL group and the nontoric accommodating IOL (Crystalens) control group.
RESULTS: The toric 1.25 D group had a statistically significantly greater percentage reduction in absolute cylinder (P < .001) and uncorrected distance visual acuity (P = .002) than the control group at the 120- to 180-day visit. The mean monocular uncorrected vision at distance, intermediate, and near was 20/25, 20/22, and 20/39, respectively, with the 1.25 D, 2.00 D, and 2.75 D toric IOLs in aggregate (toric group). In addition, 96.1% of patients (123/128) had 5.0 degrees or less absolute IOL rotation postoperatively. Regarding safety, the endpoints for preservation of corrected visual acuity and the incidence of complications and adverse events were met.
CONCLUSION: The toric IOL was safe and effective in reducing the effects of preoperative corneal astigmatism and provided excellent uncorrected distance and intermediate vision and functional near vision.
FINANCIAL DISCLOSURES: Dr. Pepose is a consultant to Bausch & Lomb and was medical monitor of this study. Drs. Buckhurst, Whitman, Feinerman, Hovanesian, Davies, Labor, and Carter are consultants to Bausch & Lomb. At the time of the study, Drs. Hayashida, and Khodai were employees of Bausch & Lomb. Drs. Colvard and Mittleman have financial or proprietary interest in any material or method mentioned.
Предметные рубрики MeSH
AgedAged, 80 and overAstigmatismBiocompatible MaterialsCataractEquipment SafetyFemaleHumansLens Implantation, IntraocularLenses, IntraocularMaleMiddle AgedPhacoemulsificationPresbyopiaProspective StudiesProsthesis DesignRefraction, OcularSilicone ElastomersSingle-Blind MethodTreatment OutcomeVisual Acuity