Gundersen Kjell Gunnar, Potvin Rick
IFocus Øyeklinikk AS, Haugesund, Norway.
Science in Vision, Akron, NY, USA.
Clin Ophthalmol. 2020 May 18;14:1337-1342. doi: 10.2147/OPTH.S255725. eCollection 2020.
To evaluate the rotational stability, visual acuity and refractive error after sulcus implantation of a secondary toric IOL.
One clinical practice in Haugesund, Norway.
Non-interventional single-arm diagnostic study.
Eligible subjects who had previous successful primary cataract or refractive lens exchange surgery in one or both eyes and the AddOn secondary toric IOL implanted in the sulcus were evaluated at a single postoperative diagnostic visit to measure visual outcomes. Subjects with surgical complications (either primary or secondary) or pathology that would affect best-corrected visual acuity (eg, amblyopia) were excluded. Clinical evaluations at the diagnostic visit included measurement of visual acuity, manifest refraction and IOL orientation.
Eighteen eyes were evaluated. After secondary IOL implantation, mean residual refractive astigmatism was significantly reduced (1.66 ± 0.92 to 0.32 ± 0.25 D). There was no appreciable change in the spherical equivalent refraction. Sixteen of 18 eyes (89%) had residual refractive astigmatism ≤0.50D, and no eye had more than 0.75D after secondary IOL implantation. Mean UCVA was 0.00 ± 0.03 logMAR, with no eyes worse than 0.10. Mean BCVA was -0.05 ± 0.03 logMAR (20/20+2), with all eyes having BCVA of 0.00 logMAR. The mean change in orientation was near zero, with a mean absolute change of 4.9 ± 3.7 degrees. Sixteen of 18 eyes (89%) had a lens orientation ≤10 degrees from intended, with no eye oriented more than 13 degrees from intended.
The AddOn toric sulcus IOL significantly reduced postoperative refractive astigmatism in patients with high astigmatism after their primary cataract or RLE surgery, providing very good uncorrected distance vision.
评估二期环曲面人工晶状体沟内植入术后的旋转稳定性、视力及屈光不正情况。
挪威豪格松的一家临床机构。
非干预性单臂诊断性研究。
对一只或双眼曾成功进行过初次白内障或屈光性晶状体置换手术且在晶状体沟内植入了AddOn二期环曲面人工晶状体的符合条件的受试者,在术后单次诊断性就诊时评估视觉效果。排除有手术并发症(原发性或继发性)或会影响最佳矫正视力的病理情况(如弱视)的受试者。诊断性就诊时的临床评估包括视力测量、显验光及人工晶状体定位。
对18只眼进行了评估。二期人工晶状体植入后,平均残余屈光性散光显著降低(从1.66±0.92 D降至0.32±0.25 D)。等效球镜度屈光不正无明显变化。18只眼中有16只(89%)在二期人工晶状体植入后残余屈光性散光≤0.50 D,且无一只眼超过0.75 D。平均裸眼视力为0.00±0.03 logMAR,无一只眼视力差于0.10。平均最佳矫正视力为-0.05±0.03 logMAR(20/20+2),所有眼最佳矫正视力均为0.00 logMAR。定位的平均变化接近零,平均绝对变化为4.9±3.7度。18只眼中有16只(89%)晶状体定位与预期相差≤10度,无一只眼与预期相差超过13度。
AddOn环曲面沟内人工晶状体显著降低了原发性白内障或屈光性晶状体置换术后高散光患者的术后屈光性散光,提供了非常好的未矫正远视力。