Rizk Islam M, Al-Hessy Abd-Almonem A, El-Khouly Sherief E, Sewelam Ashraf M
Mansoura Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura 35516, Egypt.
Int J Ophthalmol. 2019 Feb 18;12(2):284-290. doi: 10.18240/ijo.2019.02.16. eCollection 2019.
To compare Visian lens (model V4c) and Artiflex lens regarding quality (contrast sensitivity) and quantity (efficacy, predictability, safety and stability) of vision in correcting high myopia with recording and analysis of complications.
The comparative prospective study included 39 eyes of 23 patients with high myopia, 19 eyes had Visian lens implantation (model V4c) and 20 eyes had Artiflex lens implantation. The inclusion criteria were high myopia (higher than 6.0 D) and stable refraction (<0.5 D change over one year). Outcomes included assessment of safety and efficacy indices, predictability, stability, contrast sensitivity and analysis of complications at postoperative 1d, 1wk and 1, 3, 6 and 12mo. Selection of the type of phakic intraocular lens for patients was based on surgeons' preferences, which was no specific selection criteria.
After 12mo of follow up, difference in uncorrected and corrected distant visual acuity (CDVA) between both groups was statistically insignificant (UDVA for VisianV4c and Artiflex lens were 0.33±0.2 logMAR and 0.37±0.2 logMAR respectively, =0.59, CDVA for VisianV4c and Artiflex lens were 0.155±0.1 logMAR and 0.147± 0.1 logMAR respectively, =0.87). The efficacy index was 1.25 for VisianV4c lens and 0.8 for Artiflex lens, 78.9% of eyes were within one diopter spherical equivalent in Visian V4c lens group compared to 70% in the Artiflex lens group. No eye lost lines of CVDA proving a good safety index for both lenses (safety index was 1.67 for VisianV4c lens and 1.34 for Artiflex lens). Difference in contrast sensitivity between both groups was statistically insignificant (=0.15, 0.88, 0.27, 0.32 and 0.82 at five spatial frequencies).
Both Visian ICL V4c and Artiflex lenses are safe and effective with stable and predictable refraction and they have comparable contrast sensitivity outcomes with no vision threatening complications.
比较Visian晶状体（V4c型号）和Artiflex晶状体在矫正高度近视时视觉质量（对比敏感度）和数量（有效性、可预测性、安全性和稳定性）方面的差异，并记录和分析并发症。
这项前瞻性对照研究纳入了23例高度近视患者的39只眼，其中19只眼植入了Visian晶状体（V4c型号），20只眼植入了Artiflex晶状体。纳入标准为高度近视（近视度数高于6.0 D）且屈光稳定（一年内屈光变化<0.5 D）。观察指标包括安全性和有效性指标、可预测性、稳定性、对比敏感度，并在术后1天、1周、1、3、6和12个月分析并发症。根据手术医生的偏好为患者选择有晶状体眼人工晶状体的类型，没有特定的选择标准。
随访12个月后，两组间未矫正和矫正远视力（CDVA）差异无统计学意义（Visian V4c晶状体和Artiflex晶状体的未矫正远视力分别为0.33±0.2 logMAR和0.37±0.2 logMAR，P = 0.59；Visian V4c晶状体和Artiflex晶状体的矫正远视力分别为0.155±0.1 logMAR和0.147±0.1 logMAR，P = 0.87）。Visian V4c晶状体的有效性指数为1.25，Artiflex晶状体为0.8，Visian V4c晶状体组78.9%的眼等效球镜度在1屈光度以内，而Artiflex晶状体组为70%。没有眼的矫正远视力下降，表明两种晶状体的安全性指数良好（Visian V4c晶状体的安全性指数为1.67，Artiflex晶状体为1.34）。两组间对比敏感度差异无统计学意义（在五个空间频率下P分别为0.15、0.88、0.27、0.32和0.82）。
Visian ICL V4c和Artiflex晶状体在矫正高度近视时均安全有效，屈光稳定且可预测，对比敏感度结果相当，无威胁视力的并发症。
