Zhao Li-Quan, Li Liang-Mao, Liu Jun, Li Peng
Department of Ophthalmology, Pudong New Area People's Hospital Affiliated to Shanghai University of Medicine and Health Sciences, Shanghai, China.
Department of Ophthalmology, No. 181 Hospital of the PLA, Guilin, Guangxi, China.
J Ophthalmol. 2019 Jan 10;2019:3074659. doi: 10.1155/2019/3074659. eCollection 2019.
To assess the efficacy of applying bandage contact lens (BCL) in reducing the fibrotic healing response of flap margins following femtosecond laser in situ keratomileusis (FS-LASIK).
In this prospective, randomized, interventional, observer-masked trial, 41 patients (82 eyes) with myopia and/or myopic astigmatism were scheduled to undergo FS-LASIK. After surgery, patients were fitted with a BCL in one eye (BCL eyes, =41) but not in the contralateral eye (control eyes, =41), following randomized allocation of the BCL to the left or right eye of each patient. The BCL was left in place overnight and removed the following morning. All eyes subsequently received standardized postoperative treatments. Patients were followed up for 6 months. We evaluated patients' self-reported postoperative symptom scores for pain, photophobia, tearing, and foreign-body sensation. At 6 months after surgery, we examined the corneal flap margin and adjacent regions, and photographed them using slit-lamp biomicroscopy, to subjectively evaluate the wound healing response.
Postoperative pain and photophobia were milder in the BCL group than in the control group (=0.041 and =0.003, respectively), but patients felt more foreign-body sensation in the eye with a BCL than in the control eye (=0.001). There was no significant difference in tearing score between BCL eyes and control eyes (=0.118). Regarding the fibrotic healing response of the flap margin, control eyes showed a wide, bright peripheral circumferential band with a spiculated edge and high reflectivity; conversely, BCL eyes showed a markedly narrower and smoother peripheral circumferential band, with a less spiculated edge and lower reflectivity ( < 0.001).
Patients felt less discomfort in eyes treated with a BCL after FS-LASIK than in control eyes. BCL-treated eyes also had a less intense wound healing response at the flap margins than control eyes in some of patients. BCLs may merit consideration as a treatment option after FS-LASIK for special patients. This trial is registered with ChiCTR1800016579.
评估绷带式接触镜（BCL）在减少飞秒激光原位角膜磨镶术（FS-LASIK）后瓣边缘纤维化愈合反应中的疗效。
在这项前瞻性、随机、干预性、观察者盲法试验中，41例近视和/或近视散光患者（82只眼）计划接受FS-LASIK手术。术后，在随机分配BCL至每位患者的左眼或右眼后，一只眼佩戴BCL（BCL组眼，n = 41），对侧眼不佩戴（对照组眼，n = 41）。BCL过夜佩戴，次日早晨取出。所有眼睛随后接受标准化的术后治疗。患者随访6个月。我们评估了患者自我报告的术后疼痛、畏光、流泪和异物感症状评分。术后6个月，我们检查了角膜瓣边缘及相邻区域，并用裂隙灯生物显微镜拍照，以主观评估伤口愈合反应。
BCL组术后疼痛和畏光比对照组轻（分别为P = 0.041和P = 0.003），但佩戴BCL的眼睛比对照眼有更多的异物感（P = 0.001）。BCL组眼和对照组眼的流泪评分无显著差异（P = 0.118）。关于瓣边缘的纤维化愈合反应，对照组眼显示出一条宽的、明亮的周边环形带，边缘呈锯齿状且反射率高；相反，BCL组眼显示出明显更窄、更平滑的周边环形带，边缘锯齿状较少且反射率较低（P < 0.001）。
FS-LASIK术后佩戴BCL治疗的眼睛比对照眼患者感觉不适更少。在一些患者中，佩戴BCL治疗的眼睛在瓣边缘的伤口愈合反应也比对照眼弱。对于特殊患者，BCL可能值得作为FS-LASIK术后的一种治疗选择。本试验已在中国临床试验注册中心注册，注册号为ChiCTR1800016579。
