Kohnen Thomas, Marchini Giorgio, Alfonso Jose F, Bala Chandra, Cochener Beatrice, Martinez Aldo, Carreño Edgardo
From the Department of Ophthalmology, Goethe-University (Kohnen), Frankfurt, Germany; Eye Clinic, Department of Neurosciences, Biomedicine and Movement, University of Verona, AOUI-Borgo Roma Hospital (Marchini), Verona, Italy; Fernández-Vega Ophthalmological Institute, School of Medicine, University of Oviedo (Alfonso), Oviedo, Spain; Department of Ophthalmology, Macquare University (Bala), Sydney, NSW, Australia; Ophthalmology Department, University Hospital CHU (Cochener), Brest, France; Alcon Vision LLC (Martinez), Fort Worth, Texas, USA; Centro Oftalmologico Carreño (Carreño), Santiago, Chile.
J Cataract Refract Surg. 2020 Aug;46(8):1142-1148. doi: 10.1097/j.jcrs.0000000000000232.
To evaluate visual acuity (VA) and safety of the new AcrySof IQ PanOptix presbyopia-correcting IOL at 12 months postimplantation.
Seventeen sites in Europe, Australia, and South America.
Prospective, single-arm, nonmasked, nonrandomized study.
Of 167 patients enrolled, 149 received study IOLs in both eyes; 145 completed the study. Binocular uncorrected distance VA (UDVA; 4 m), monocular corrected distance VA (CDVA), binocular distance-corrected intermediate VA (DCIVA; 60 cm and 80 cm), binocular uncorrected near VA (UNVA; 40 cm), and binocular defocus curves were evaluated. Safety was assessed by monitoring adverse events (AEs).
Of 149 patients, 92 patients (62%) were women and 139 patients (93%) were white; mean ± SD age was 68.9 ± 9.3 years. At 12 months, mean binocular UDVA was 0.02 ± 0.11 logarithm of the minimum angle of resolution (logMAR); monocular CDVA was 0.01 ± 0.13 logMAR (first eye) and 0.01 ± 0.10 logMAR (second eye); binocular DCIVA was 0.04 ± 0.12 logMAR and 0.08 ± 0.14 logMAR at 60 cm and 80 cm, respectively; and binocular UNVA was 0.07 ± 0.11 logMAR. At 6 months, mean binocular defocus curve VA (0.00 diopter [D] to -3.00 D) ranged from -0.04 to 0.13 logMAR. Binocular VA at distance (0.00 D), intermediate (-1.50 D), and near (-2.50 D) was -0.04 ± 0.11 logMAR, 0.07 ± 0.13 logMAR, and 0.07 ± 0.13 logMAR, respectively. Serious ocular AE rates were 1.4% or less in first and second eyes. Posterior capsulotomy rates were 3.4% (first eye) and 2.7% (second eye).
The study IOL provided good VA outcomes. Defocus curve showed VA of 20/25 Snellen or better from near to intermediate distance. Rates of serious and nonserious AEs were low.
评估新型AcrySof IQ PanOptix老视矫正人工晶状体植入术后12个月时的视力（VA）及安全性。
欧洲、澳大利亚和南美洲的17个研究点。
前瞻性、单臂、非盲、非随机研究。
167例入组患者中，149例双眼植入研究用人工晶状体；145例完成研究。评估双眼未矫正远视力（UDVA；4米）、单眼矫正远视力（CDVA）、双眼矫正远视力下的中间视力（DCIVA；60厘米和80厘米）、双眼未矫正近视力（UNVA；40厘米）以及双眼散焦曲线情况。通过监测不良事件（AE）评估安全性。
149例患者中，92例（62%）为女性，139例（93%）为白人；平均年龄±标准差为68.9±9.3岁。12个月时，双眼平均UDVA为0.02±0.11最小分辨角对数（logMAR）；单眼CDVA，第一只为0.01±0.13 logMAR，第二只为0.01±0.10 logMAR；双眼DCIVA在60厘米和80厘米处分别为0.04±0.12 logMAR和0.08±0.14 logMAR；双眼UNVA为0.07±0.11 logMAR。6个月时，双眼散焦曲线视力（0.00屈光度[D]至 -3.00 D）范围为 -0.04至0.13 logMAR。远距（0.00 D）、中间距（-1.50 D）和近距（-2.50 D）的双眼视力分别为 -0.04±0.11 logMAR、0.07±0.13 logMAR和0.07±0.13 logMAR。第一只眼和第二只眼的严重眼部不良事件发生率均为1.4%或更低。后囊切开率第一只眼为3.4%，第二只眼为2.7%。
研究用人工晶状体提供了良好的视力结果。散焦曲线显示从近距到中间距的视力达到20/25 Snellen或更好。严重和非严重不良事件发生率较低。
