有晶状体眼后房型植入性Collamer屈光晶状体矫正近视的疗效观察

Outcome after treament of myopia with implantable Collamer lens

目的研究有晶状体眼后房型植入性Collamer屈光晶状体矫治近视的临床疗效。方法前瞻性非随机临床试验研究。2008年7月至2010年2月行有晶状体眼后房型植人性Collamer屈光晶状体手术（ICL）48例（91只眼）。分别于手术前、术后1周，1、3、6及12个月随访裸眼视力、最佳矫正视力、屈光度数、对比敏感度、波阵面像差、前房深度、ICL与透明晶状体的间隙以及角膜内皮细胞计数和手术并发症，并采用配对t检验对数据进行统计学分析。结果手术全部成功。手术后患者平均随访时间（9．54±4．12）个月；58只眼（64％）术后1周裸眼视力（uncorrected visual acuity，UCVA）达到1．0及以上，69只眼（75．9％）术后1周最佳矫正视力（BCVA）较术前提高1行及以上；对比敏感度和眩光对比敏感在6周／度频率手术前后差异无统计学意义（t=-0．969，P〉0．05），3、12、18周／度手术后显著提高，差异有统计学意义（t=-3．655，-2．748，-3．081；P〈0．01）。波阵面像差手术后较术前减小。手术后前房深度平均较术前减少8．92％（1周）。术后晶状体间隙平均（452±216．38）μm（6个月），最大1080μm，最小130μm，并且各随访时间差异无统计学意义（t=-0．200，P〉0．05）。手术后有2只眼（2．1％）前房较术前明显变浅（降低31％），13只眼（14．3％）l周随访时有一过性眼压升高。结论有晶状体眼后房型可植入性Collamer屈光晶状体矫正近视具有良好的可预测性，安全性、有效性和稳定性（f中华眼科杂志，2011，47：146—150）

Objective To evaluate the efficacy, predictability, stability, and safety of the surgical correction myopia using implantable Collamer lenses （ICL） in phakic eyes. Methods A prospective study was performed to analyze 91 eyes of 48 patients who had the implantation of ICL for the treatment of myopia from July 2008 to February 2010. Patients were examined preoperatively and followed at 1 week, 1, 3, 6, and 12 months postoperatively. The examinations included the uncorrected visual acuity （ UCVA ）, best corrected visual acuity （ BCVA）, refraction, contrast sensitivity, wavefront aberration, intraocular pressure, space between crystal lens and intraocular lens （vault） , endothelial cell density （ECD）, anterior chamber depth （ACD）, surgical complication, etc. Results Successful implantation was achieved in all patients. The mean follow-up time was （9. 54 ±4. 12） months （SD）（ range 1 to 12 months）. The mean preoperative SE was -12. 38 diopters （D） （ range - 5.0D to - 23.0D）. Postoperatively, UCVA was maintained or improved in all eyes. UCVA achieved 1.0 in 58 eyes （64%） and BCVA gained more than 1 line in 69 eyes （75.9%）. The glare and no glare contrast sensitivity were improved at 3cd, 12cd and 18cd, with the exception of 6cd. The aberration decreased in RMS, spherical and coma. Post operative ACD （ 1 week after operation） diminished 8.92% as compared with the preoperative ACD. The mean vaulting was （452 ±216. 38） μm （6 months） and ranged 130-1080 μm at different follow-up periods. There was no statistically significant difference in vaulting between postoperative data at different periods （t = 0. 200 ,P 〉 0. 05 ）. The mean postoperative ECD decreased but had no statistically difference compared with the preoperative ECD. ACD decreased 31% after surgery in 2 eyes （2. 1% ）. Transient high IOP was observed in 13 eyes （2. 1% ）one week after the operation. Conclusion These results indicate that ICL implantation in the treatment of myopia is efficient, predictable , safe, and reliable. （Chin J Opbthalmol, 2011,47：146-150）