Ophthalmology · 2014
Quality of vision after bilateral multifocal intraocular lens implantation: a randomized trial--AT LISA 809M versus AcrySof ReSTOR SN6AD1.
Сравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Maurino Vincenzo, Allan Bruce D, Rubin Gary S, Bunce Catey, Xing Wen, Findl Oliver, Moorfields IOL Study Group
Аннотация
PURPOSE: To compare postoperative visual symptoms and spectacle freedom after bilateral implantation of the AT LISA 809M (Carl Zeiss Meditec, Jena, Germany) versus the AcrySof ReSTOR SN6AD1 (Alcon Laboratories, Irvine, CA) multifocal intraocular lens (IOL).
DESIGN: Double-masked, prospective, randomized, controlled clinical trial.
PARTICIPANTS: A total of 188 patients undergoing bilateral sequential cataract surgery or bilateral refractive lens exchange.
METHODS: Patients were preoperatively randomized (allocation ratio 1:1) to bilateral implantation with the AT LISA 809M IOL or ReSTOR SN6AD1 IOL. Postoperative outcomes were assessed 4 to 8 months after second eye surgery.
MAIN OUTCOME MEASURES: The primary outcome was visual symptoms evaluated with the Quality of Vision (QoV) questionnaire. Secondary outcomes included other questionnaire data (CatQuest-9SF, spectacle independence, vision satisfaction, and dysphotopsia) and visual function measures (near, intermediate, and distance visual acuity, binocular reading speed [International Reading Speed Texts], contrast sensitivity, and forward light scatter). Adverse events, including intraoperative and postoperative complications, also were evaluated.
RESULTS: There was no significant difference between IOL groups in Rasch-adjusted QoV scores for frequency (P = 0.95), severity (P = 0.56), and bothersomeness (P = 0.34) of visual symptoms; median (interquartile) scores for these QoV subscales were 29 (15-37), 22 (13-27), and 14 (0-29) for the AT LISA 809M IOL group, respectively, and 32 (15-37), 22 (13-30), and 14 (0-29) for the ReSTOR SN6AD1 IOL group, respectively. Halo was the most prominent dysphotopsia symptom, with 6% in both IOL groups reporting halo symptoms as very bothersome. Complete spectacle independence was achieved in 69 of 84 (82.1%) AT LISA 809M recipients and 66 of 85 (77.6%) ReSTOR SN6AD1 recipients (P = 0.57). Preferred reading distance was slightly nearer for the AT LISA 809M IOL. There were no statistically significant differences in any of the other secondary outcome measures.
CONCLUSIONS: Visual symptoms were similar after bilateral implantation of the AT LISA 809M and ReSTOR SN6AD1 IOLs. Both these diffractive bifocal IOLs produce high levels of spectacle independence and patient satisfaction. However, a small but clinically significant minority of patients remained symptomatic and dissatisfied with visual results 4 to 8 months after surgery.
DESIGN: Double-masked, prospective, randomized, controlled clinical trial.
PARTICIPANTS: A total of 188 patients undergoing bilateral sequential cataract surgery or bilateral refractive lens exchange.
METHODS: Patients were preoperatively randomized (allocation ratio 1:1) to bilateral implantation with the AT LISA 809M IOL or ReSTOR SN6AD1 IOL. Postoperative outcomes were assessed 4 to 8 months after second eye surgery.
MAIN OUTCOME MEASURES: The primary outcome was visual symptoms evaluated with the Quality of Vision (QoV) questionnaire. Secondary outcomes included other questionnaire data (CatQuest-9SF, spectacle independence, vision satisfaction, and dysphotopsia) and visual function measures (near, intermediate, and distance visual acuity, binocular reading speed [International Reading Speed Texts], contrast sensitivity, and forward light scatter). Adverse events, including intraoperative and postoperative complications, also were evaluated.
RESULTS: There was no significant difference between IOL groups in Rasch-adjusted QoV scores for frequency (P = 0.95), severity (P = 0.56), and bothersomeness (P = 0.34) of visual symptoms; median (interquartile) scores for these QoV subscales were 29 (15-37), 22 (13-27), and 14 (0-29) for the AT LISA 809M IOL group, respectively, and 32 (15-37), 22 (13-30), and 14 (0-29) for the ReSTOR SN6AD1 IOL group, respectively. Halo was the most prominent dysphotopsia symptom, with 6% in both IOL groups reporting halo symptoms as very bothersome. Complete spectacle independence was achieved in 69 of 84 (82.1%) AT LISA 809M recipients and 66 of 85 (77.6%) ReSTOR SN6AD1 recipients (P = 0.57). Preferred reading distance was slightly nearer for the AT LISA 809M IOL. There were no statistically significant differences in any of the other secondary outcome measures.
CONCLUSIONS: Visual symptoms were similar after bilateral implantation of the AT LISA 809M and ReSTOR SN6AD1 IOLs. Both these diffractive bifocal IOLs produce high levels of spectacle independence and patient satisfaction. However, a small but clinically significant minority of patients remained symptomatic and dissatisfied with visual results 4 to 8 months after surgery.