有晶状体眼可折叠房角支撑型人工晶状体植入术矫正高度近视的初步观察

Clinical research of the phakic foldable angle-supported intraocular lens for the correction of high myopia

目的评估可折叠房角支撑型人工晶状体（IOL）植入术矫正高度近视的安全性、有效性、可预测性及稳定性。方法收集2010年4月至2011年7月在我院接受可折叠房角支撑型IOL（CACHET房角支撑型IOL，美国ALCON公司）植入术的高度近视患者共15人（29只眼），术后随访1年。术前平均球镜度（-12．08±2．44）D（范围：-8．75～-16．50D）。术后1个月、3个月、6个月、1年检查裸眼视力（UCVA）、最佳矫正视力（BSCVA）、角膜内皮密度、IOL前房稳定性及手术并发症，评估手术的安全性、有效性、可预测性及稳定性。对角膜内皮细胞密度采用“检验进行统计学分析。结果术后1年，BSCVA≥0．6者为100％，BSCVA≥1．0者89．7％（26／29）；BSCVA较术前下降者为0眼；较术前无变化的占62．1％（18／29）；较术前提高1行的占31．0％（9／29）；较术前提高2行的占3．4％（1／29）；较术前提高大于2行的占3．4％（1／29）；手术安全指数为1．13（1．08／0．96）。术后1年，100％术眼UCVA／〉0．5，UCVA≥1．0者58．6％（17／29），UCVA／〉0．8者86．2％（25／29），UCVA≥0．6者93．1％（27／29）；手术有效指数为1．03（0．99／0．96）。术后1年，平均球镜度为（-0．23±0．25）D；术后实际屈光度与术前目标屈光度差异±0．50D以内者占100％；平均角膜内皮细胞密度变化为-0．23％±4．80％。术后并发症主要为术后早期眼压升高，占17．2％，仅见于术后当日。眩光及光晕主要出现于术后1个月内，分别占6．9％（2／29）、13．8％（4／29），不影响夜间驾车。结论经过1年的临床观察，显示可折叠房角支撑型人工晶状体植入术矫正高度的安全性、有效性、可预测性强，IOL前房稳定性良好，手术并发症少。由于术后随访时间有限，更长期的临床随访观察很有必要。

Objective To assess the safety, efficacy, predictability and stability of the phakic foldable angle-supported intraocular lens （IOL） （CACHET IOL, Aleon Inc. , USA. ） for correction of high- to-extremely high myopia in adults. Methods In this prospective study, 29 eyes of 15 patients were implanted with CACHET phakic angle-supported IOL and followed for 1 year postoperatively. Preoperative manifest refractive sphere was - 12. 08 ± 2. 44 diopters （ D）. Visual acuity （ uncorrected visual acuity, UCVA ; best spectacle-corrected visual acuity, BSCVA ） , predictability and stability of manifest refraction spherical equivalent （MRSE） , adverse events, and endothelial cell density were analyzed primarily during 1 -year of follow-up. Results After 1 year of follow-up, a BSCVA of 0. 6 or better was achieved by 100% of eyes; 9.7% （26/29） had a BSCVA of 1.0 or better; no eyes lost≥1 line BSCVA, 62. 1% （18/29） had no change in lines of BSCVA, 31.0% （9/29） gained 1 line of BSCVA, 3.4% （1/29） gained 2 line of BSCVA, and 3.4% （1/29） gained more than 2 line of BSCVA; the safety index was 1.13 （ 1.08/0. 96） ; UCVA of 1.0 or better was achieved by 58.6% （ 17/29）, 100% had an UCVA of 0. 5 or better, 86. 2% （25/29） of eyes achieved a UCVA of 0. 8 or better, and 93. 1% （27/29） of eyes achieved a UCVA of O. 6 or better; the efficacy index was 1.03 （0. 99/0. 96）. The overall mean percentage change in endothelial cell density 1 year after surgery was -0. 23% ±4. 80%. Five eyes （ 17.2% ） had increased intraoeular pressure （IOP） on the day of surgery. No pupil ovalization, pupillary block, or retinal detachment events were observed. Glare（6. 9%, 2/29） and halo（13.8% ,4/29） mainly appeared in the first month after surgery, and had no influence on driving in night. Conclusions After 1 year of follow-up, the implantation of phakic foldable angle-supported IOL was proved to be safe, effective and predictable with minimal complications in patients with high myopia. Due to the limitation of visiting time, long-term of clinical investigation is necessary to verify the safety and efficacy of this IOL.