Al Sabaani Nasser, Al Assiri Abdullah, Al Torbak Abdullah, Al Motawa Saeed
Anterior Segment Division, King Khaled Eye Specialist Hospital, Riyadh, Saudi Arabia.
Saudi J Ophthalmol. 2013 Oct;27(4):259-66. doi: 10.1016/j.sjopt.2013.06.009. Epub 2013 Jul 1.
To assess the safety and efficacy of the implantable contact lens (ICL™) to treat myopia.
Clinical, retrospective, single center, non-randomized case series.
Sixty-nine eyes of 46 patients with myopia ranging from -3.00 to 25.00 D were included in this study.
Implantation of the ICL™.
Uncorrected Visual Acuity (UCVA), refraction, best spectacle corrected visual acuity (BSCVA), adverse events, operative and postoperative complications, subjective assessment and symptoms.
The mean follow-up was 12.35 ± 6.13 (SD) months (range, 6 months-32 months). At the last visit, 49.20% of eyes had 20/20 or better UCVA compared to preoperative 20/20 or better BSCVA of 31.9% of eyes; 69.23% of eyes had postoperative UCVA better than or equal to preoperative BSCVA. The mean manifest refractive cylinder was 1.93 ± 1.21 D at baseline and 1.00 ± 0.92 D postoperatively. The mean manifest refraction spherical equivalent (MRSE) was -11.70 ± 4.24 D preoperatively and -0.69 ± 1.13 D postoperatively. A total of 69.8% of eyes were within ±0.5 D of the predicted MRSE; 84.1% were within ±1.0 D, and 88.90% were within ±2.0 D. BSCVA of 20/20 or better was achieved in 64.6% of eyes postoperatively, compared to 31.9% preoperatively. Mean improvement in BSCVA was 1line. One eye (1.5%) lost ⩾2 lines of BSCVA at the last visit, whereas 20% of eyes improved by ⩾2 lines. A total of 56.92% of cases gained ⩾1 line of BSCVA and 4.62% of cases lost ⩾1 line. Four ICL lenses were removed without significant loss of BSCVA, and 2 eyes with clinically significant lens opacities were observed. Four eyes (5.8%) developed a pupillary block the first day postoperatively. One eye (1.4%) developed a hypotony and AC shallowing.
Implantation of ICL for the correction of myopia was a safe procedure with good visual and refractive results from the early postoperative period to 1 year. Long-term follow-up is required to confirm the long-term safety of this implant.
评估可植入式接触镜(ICL™)治疗近视的安全性和有效性。
临床、回顾性、单中心、非随机病例系列研究。
本研究纳入了46例近视患者的69只眼,近视度数范围为-3.00至-25.00D。
植入ICL™。
裸眼视力(UCVA)、屈光状态、最佳矫正视力(BSCVA)、不良事件、手术及术后并发症、主观评估和症状。
平均随访时间为12.35±6.13(标准差)个月(范围为6个月至32个月)。在最后一次随访时,49.20%的眼睛UCVA达到20/20或更好,而术前只有31.9%的眼睛BSCVA达到20/20或更好;69.23%的眼睛术后UCVA优于或等于术前BSCVA。基线时平均显性屈光柱镜为1.93±1.21D,术后为1.00±0.92D。术前平均显性屈光球镜等效值(MRSE)为-11.70±4.24D,术后为-0.69±1.13D。共有69.8%的眼睛屈光状态在预测MRSE的±0.5D范围内;84.1%在±1.0D范围内,88.90%在±2.0D范围内。术后64.6%的眼睛BSCVA达到20/20或更好,术前为31.9%。BSCVA平均提高了1行。最后一次随访时,1只眼(1.5%)BSCVA下降了≥2行,而20%的眼睛提高了≥2行。共有56.92%的病例BSCVA提高了≥1行,4.62%的病例下降了≥1行。取出了4片ICL镜片,BSCVA无明显下降,观察到2只眼出现具有临床意义的晶状体混浊。4只眼(5.8%)术后第一天发生瞳孔阻滞。1只眼(1.4%)发生低眼压和前房变浅。
植入ICL矫正近视是一种安全的手术,术后早期至1年视觉和屈光效果良好。需要长期随访以确认该植入物的长期安全性。