Doroodgar Farideh, Niazi Feazollah, Sanginabadi Azad, Niazi Sana, Baradaran-Rafii Alireza, Alinia Cyrus, Azargashb Eznollah, Ghoreishi Mohammad
Ophthalmology Department, Eye Research Center Tehran University of Medical Sciences, Tehran, Tehran, Iran.
Shahid Beheshti University of Medical Sciences and Health Services , Chamran Highway, Daneshjoo Street, Tehran, Iran, Thran, Tehran, Iran.
BMJ Open Ophthalmol. 2017 Sep 28;2(1):e000090. doi: 10.1136/bmjophth-2017-000090. eCollection 2017.
To report on 4-year postoperative visual performance with the toric implantable collamer lens (TICL) for stable keratoconus after sequential procedure (corneal collagen crosslinking plus TICL implantation).
Forty eyes of 24 patients with stable keratoconus with myopia between 0.00 and -18.00 dioptres (D) and astigmatism between 1.25 and 8.00 D were evaluated in this prospective interventional study (https://clinicaltrials.gov/ct2/show/NCT02833649). We evaluated refraction, visual outcomes, astigmatic changes analysed by Alpins vector, contrast sensitivity, aberrometry, modulation transfer functions (MTFs), defocus curve, and operative and postoperative complications.
At 4-year follow-up, 45% had 20/20 vision or better and 100% had 20/40 or better uncorrected visual acuity (UCVA). Vector analysis of refractive astigmatism shows that the surgically induced astigmatism (SIA) (3.20±1.46 D) was not significantly different from the target induced astigmatism (TIA) (3.14±1.42 D) (p=0.620). At 4 years postoperatively, none of the eyes showed a decrease in UCVA, in contrast to 24 eyes in which UCVA was increased by ≥1 lines, with contrast sensitivity and improvement in total aberrations and MTF value at 5 per degree (*p=0.004) after TICL implantation. The cumulative 4-year corneal endothelial cell loss was ≤5%. No patients reported dissatisfaction. At the end of follow-up, the vault was 658±54.33m (range, 500-711) and the intraocular pressure was 11.7±2.08 mm Hg. Occurrences of glare and night-driving troubles diminished after TICL surgery.
The results from this standardised clinical investigation support TICL implantation from clinical and optical viewpoints in patients with stable keratoconus.
NCT02833649, Pre-results.
报告采用环曲面可植入角膜接触镜（TICL）对圆锥角膜患者进行序贯手术（角膜胶原交联联合TICL植入）后4年的视觉表现。
在这项前瞻性干预研究（https://clinicaltrials.gov/ct2/show/NCT02833649）中，对24例圆锥角膜稳定患者的40只眼睛进行了评估，这些患者的近视度数在0.00至-18.00屈光度（D）之间，散光度数在1.25至8.00 D之间。我们评估了屈光、视觉结果、通过阿尔平斯矢量分析的散光变化、对比敏感度、像差测量、调制传递函数（MTF）、散焦曲线以及手术和术后并发症。
在4年随访时，45%的患者视力达到20/20或更好，100%的患者未矫正视力（UCVA）达到20/40或更好。屈光性散光的矢量分析显示，手术诱导散光（SIA）（3.20±1.46 D）与目标诱导散光（TIA）（3.14±1.42 D）无显著差异（p = 0.620）。术后4年，没有眼睛的UCVA下降，相比之下，24只眼睛的UCVA提高了≥1行，TICL植入后对比敏感度以及每度5周时总像差和MTF值均有改善（*p = 0.004）。4年累计角膜内皮细胞损失≤5%。没有患者表示不满意。随访结束时，前房深度为658±54.33μm（范围，500 - 711），眼压为11.7±2.08 mmHg。TICL手术后眩光和夜间驾驶问题的发生率降低。
这项标准化临床研究的结果从临床和光学角度支持对圆锥角膜稳定患者植入TICL。
NCT02833649，预结果。
