Maxwell Andrew, Holland Edward, Cibik Lisa, Fakadej Anna, Foster Gary, Grosinger Les, Moyes Andrew, Nielsen Stephen, Silverstein Steven, Toyos Melissa, Weinstein Arthur, Hartzell Scott
From the California Eye Institute (Maxwell), Fresno, California; Cincinnati Eye Institute (Holland), Cincinnati, Ohio; Associates in Ophthalmology (Cibik), West Mifflin and the Eye Center of Central PA (Hartzell), Allenwood, Pennsylvania; Carolina Eye Associates, PA (Fakadej), Southern Pines, North Carolina; Eye Center of Northern Colorado, PC (Foster), Fort Collins, Colorado; Grosinger, Spigelman & Grey Eye Surgeons, PC (Grosinger), Bloomfield Hills, Michigan; Moyes Eye Center, PC (Moyes) and Silverstein Eye Centers (Silverstein), Kansas City, Missouri; Nielsen Eye Center (Nielsen), Quincy, Massachusetts; Toyos Clinic (Toyos), Nashville, Tennessee; Eye Associates of New Mexico (Weinstein), Albuquerque, New Mexico, USA.
From the California Eye Institute (Maxwell), Fresno, California; Cincinnati Eye Institute (Holland), Cincinnati, Ohio; Associates in Ophthalmology (Cibik), West Mifflin and the Eye Center of Central PA (Hartzell), Allenwood, Pennsylvania; Carolina Eye Associates, PA (Fakadej), Southern Pines, North Carolina; Eye Center of Northern Colorado, PC (Foster), Fort Collins, Colorado; Grosinger, Spigelman & Grey Eye Surgeons, PC (Grosinger), Bloomfield Hills, Michigan; Moyes Eye Center, PC (Moyes) and Silverstein Eye Centers (Silverstein), Kansas City, Missouri; Nielsen Eye Center (Nielsen), Quincy, Massachusetts; Toyos Clinic (Toyos), Nashville, Tennessee; Eye Associates of New Mexico (Weinstein), Albuquerque, New Mexico, USA.
J Cataract Refract Surg. 2017 Jan;43(1):29-41. doi: 10.1016/j.jcrs.2016.10.026.
To assess the effectiveness and safety of a multifocal intraocular lens (IOL) with +2.5 diopter (D) additional power compared with a monofocal IOL.
Fifteen sites in the United States.
Prospective randomized patient- and observer-masked clinical trial.
Randomized patients received multifocal or monofocal IOLs bilaterally. Visual acuity (33 cm, 40 cm, 53 cm, 60 cm, 4 m) was measured; safety was assessed through adverse event rates. Patient-reported visual outcomes were evaluated using the Visual Tasks questionnaire. The frequency and severity of visual disturbances were evaluated using the Assessment of Photic Phenomena and Lens EffectS questionnaire.
The multifocal IOL (n = 155) provided better corrected distance visual acuity at 53 cm than the monofocal IOL (n = 165) (0.322 versus 0.512 logMAR; between-group difference, -0.190 logMAR; P < .0001) and 40 cm but not at 4 m. Ocular adverse event rates were less than 3.84% in both groups. Serious adverse event rates were comparable between the 2 IOL types. Patients with multifocal IOLs reported less difficulty with near tasks (with and without correction) and intermediate tasks (without correction). Difficulty with extended-intermediate and distance tasks was similar between groups. The most frequently reported self-rated severe phenomena were halos, starbursts, and glare. Most patients (monofocal ≥72%; multifocal ≥73%) reported never experiencing blurred, distorted, or double vision.
The +2.5 D multifocal IOL provided better vision at 40 cm and 53 cm and similar vision at 4 m compared with the monofocal IOL. Safety profiles and visual phenomena were comparable between groups.
评估与单焦点人工晶状体相比，附加2.5屈光度（D）的多焦点人工晶状体（IOL）的有效性和安全性。
美国的15个地点。
前瞻性随机、患者和观察者双盲临床试验。
随机分组的患者双侧接受多焦点或单焦点IOL。测量视力（33厘米、40厘米、53厘米、60厘米、4米）；通过不良事件发生率评估安全性。使用视觉任务问卷评估患者报告的视觉结果。使用光现象和晶状体效应评估问卷评估视觉干扰的频率和严重程度。
多焦点IOL组（n = 155）在53厘米处的矫正远视力优于单焦点IOL组（n = 165）（最小分辨角对数[logMAR]分别为0.322和0.512；组间差异为-0.190 logMAR；P <.0001），在40厘米处也是如此，但在4米处并非如此。两组的眼部不良事件发生率均低于3.84%。两种IOL类型的严重不良事件发生率相当。多焦点IOL患者报告在近视力任务（无论是否矫正）和中视力任务（未矫正）中困难较少。两组在远-中视力和远视力任务中的困难程度相似。最常报告的自评严重现象是光晕、星芒和眩光。大多数患者（单焦点≥72%；多焦点≥73%）报告从未经历过视力模糊、变形或复视。
与单焦点IOL相比，附加2.5 D的多焦点IOL在40厘米和53厘米处视力更好，在4米处视力相似。两组的安全性和视觉现象相当。
