Carballo-Alvarez Jesús, Vazquez-Molini Jose M, Sanz-Fernandez Juan C, Garcia-Bella Javier, Polo Vicente, García-Feijoo Julián, Martinez-de-la-Casa Jose M
Facultad de Óptica y Optometría, Universidad Complutense de Madrid, Madrid, Spain.
Servicio de Oftalmologia, Hospital Clinico San Carlos; Departamento de Oftalmologia, Facultad de Medicina, Universidad Complutense de Madrid; and Instituto de Investigacion Sanitaria del Hospital Clinico San Carlos (IdISSC), Madrid, Spain.
BMC Ophthalmol. 2015 Mar 14;15:26. doi: 10.1186/s12886-015-0012-4.
In recent years new models of intraocular lenses are appearing on the market to reduce requirements for additional optical correction. The purpose of this study is to assess visual outcomes following bilateral cataract surgery and the implant of a FineVision® trifocal intraocular lens (IOL).
Prospective, nonrandomized, observational study. Vision was assessed in 44 eyes of 22 patients (mean age 68.4 ± 5.5 years) before and 3 months after surgery. Aberrations were determined using the Topcon KR-1 W wave-front analyzer. LogMAR visual acuity was measured at distance (corrected distance visual acuity, CDVA 4 m), intermediate (distance corrected intermediate visual acuity, DCIVA 60 cm) and near (distance corrected near visual acuity, DCNVA 40 cm). The Pelli-Robson letter chart and the CSV-1000 test were used to estimate contrast sensitivity (CS). Defocus curve testing was performed in photopic and mesopic conditions. Adverse photic phenomena were assessed using the Halo v1.0 program.
Mean aberration values for a mesopic pupil diameter were: total HOA RMS: 0.41 ± 0.30 μm, coma: 0.32 ± 0.22 μm and spherical aberration: 0.21 ± 0.20 μm. Binocular logMAR measurements were: CDVA -0.05 ± 0.05, DCIVA 0.15 ± 0.10, and DCNVA 0.06 ± 0.10. Mean Pelli-Robson CS was 1.40 ± 0.14 log units. Mean CSV100 CS for the 4 frequencies examined (A: 3 cycles/degree (cpd), B: 6 cpd, C: 12 cpd, D: 18 cpd) were 1.64 ± 0.14, 1.77 ± 0.18, 1.44 ± 0.24 and 0.98 ± 0.24 log units, respectively. Significant differences were observed in defocus curves for photopic and mesopic conditions (p < 0.0001). A mean disturbance index of 0.28 ± 0.22 was obtained.
Bilateral FineVision IOL implant achieved a full range of adequate vision, satisfactory contrast sensitivity, and a lack of significant adverse photic phenomena.
Eudract Clinical Trials Registry Number: 2014-003266-2.
近年来,市场上出现了新型人工晶状体模型,以减少额外光学矫正的需求。本研究的目的是评估双侧白内障手术及植入FineVision®三焦点人工晶状体(IOL)后的视觉效果。
前瞻性、非随机、观察性研究。对22例患者(平均年龄68.4±5.5岁)的44只眼在手术前和手术后3个月进行视力评估。使用Topcon KR-1 W波前分析仪测定像差。在远距离(矫正远距离视力,CDVA 4米)、中距离(远距离矫正中距离视力,DCIVA 60厘米)和近距离(远距离矫正近距离视力,DCNVA 40厘米)测量LogMAR视力。使用贝利-罗伯逊字母表和CSV-1000测试评估对比敏感度(CS)。在明视和暗视条件下进行散焦曲线测试。使用Halo v1.0程序评估不良光现象。
暗视瞳孔直径下的平均像差值为:总高阶像差均方根(HOA RMS):0.41±0.30μm,彗差:0.32±0.22μm,球差:0.21±0.20μm。双眼LogMAR测量值为:CDVA -0.05±0.05,DCIVA 0.15±0.10,DCNVA 0.06±0.10。平均贝利-罗伯逊对比敏感度为1.40±0.14对数单位。所检查的4个频率(A:3周/度(cpd),B:6 cpd,C:12 cpd,D:18 cpd)的平均CSV100对比敏感度分别为1.64±0.14、1.77±0.18、1.44±0.24和0.98±0.24对数单位。在明视和暗视条件下的散焦曲线中观察到显著差异(p<0.0001)。获得的平均干扰指数为0.28±0.22。
双侧植入FineVision人工晶状体可实现全方位的良好视力、令人满意的对比敏感度,且无明显不良光现象。
欧洲临床试验注册编号:2014-003266-2。