背景:探讨巩膜紫外线A(UVA)交联(巩膜CXL)对病理性失明的可行性和安全性。
方法:这是一个前瞻性的,观察性临床研究。纳入5例因病理性近视性黄斑病变导致的单眼盲患者。具有低于0.05的最佳矫正视力(BCVA)的眼睛被定义为实验眼睛。同伴的眼睛被定义为对照眼睛。患者首先在对照眼中接受后巩膜加固(PSR)手术。此后,在同一天在实验眼中进行巩膜CXL手术。视敏度,BCVA,裂隙灯生物显微镜检查,眼内压测量,角膜镜检,轴长测量,眼底扩大瞳孔,彩色眼底摄影,全场闪光视网膜电图,光学相干层析成像,在基线时进行彩色多普勒血流成像,1周,1个月,3个月,6个月,手术后12个月.
结果:术后和整个随访期间均未观察到炎症迹象。视网膜裂得到了改善,而巩膜CXL后脉络膜新生血管纤维化和视网膜和脉络膜萎缩没有改变。眼动脉无统计学差异,视网膜中央动脉,彩色多普勒血流显像或视网膜厚度的睫状后动脉参数,在实验和对照眼中,在基线,1周,1个月,3个月,或12个月(P>0.05)。
结论:这项初步研究验证了巩膜CXL治疗人类失明的可行性和安全性。人眼巩膜上的UVA-CXL在未来预防进行性病理性近视方面似乎具有与PSR相同的效果。
背景:中国临床试验注册中心(ChiCTR2100042422)。
BACKGROUND: To investigate the feasibility and safety of scleral ultraviolet A (UVA) cross-linking (scleral CXL) on pathologically blindness.
METHODS: This was a prospective, observational clinical
study. Five patients with monocular blindness due to pathological myopic maculopathy were enrolled. Eyes with best corrected visual acuity (BCVA) under 0.05 were defined as experimental eyes. The fellow eyes were defined as control eyes. Patients first underwent posterior scleral reinforcement (PSR) surgery in the control eye. Thereafter, scleral CXL surgery was performed in the experimental eye on the same day. Visual acuity, BCVA, slit lamp biomicroscopic examination, intraocular pressure measurement, corneal specula microscopies, axis length measurement, funduscopy with pupil dilation, color fundus photography, full-field flash electroretinography, optical coherence tomography, and color Doppler flow imaging were performed at baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery.
RESULTS: No signs of inflammation were observed after operation and throughout the follow-up period. Retinoschisis was improved, while choroidal neovascularization fibrosis and retinal and choroidal atrophy were unchanged after scleral CXL. There were no statistically significant differences in the ophthalmic artery, central retinal artery, and posterior ciliary artery parameters of color Doppler flow imaging or in retinal thickness, within experimental and control eyes, at baseline, 1 week, 1 month, 3 months, or 12 months (P > 0.05).
CONCLUSIONS: This pilot
study verified the feasibility and safety of scleral CXL on human blindness. The UVA-CXL on the sclera of human eyes seems to have the same effect as PSR in preventing progressive pathological myopia in the future.
BACKGROUND: Chinese Clinical
Trial Registry (ChiCTR2100042422).