目的:比较外用他克莫司和经上皮光疗性角膜切削术(Te-PTK)治疗腺病毒角膜上皮下浸润(SEIs)的角膜光密度测定和总角膜高阶像差(HOAs)的变化。
方法:这是一项干预性前瞻性随机研究,包括35例有症状的腺病毒角膜SEIs患者的63只眼,持续至少6个月。所有患者先前都接受了与不满意的反应和/或并发症相关的局部类固醇治疗。患者被分为三组:(1)Te-PTK组:Te-PTK和MMC0.02%由Technolas进行;Teneo准分子激光;(2)他克莫司组:他克莫司0.03%软膏每天一次,持续2-6个月;治疗终点基于角膜光密度测定的改善,BCVA,和OSDI;(3)对照组:不进行干预。BCVA,角膜密度测定法,在基线时使用PentacamHR进行总角膜高阶像差(HOAs)评估,1周,然后是1、3、6和12个月的研究。
结果:所有组之间的研究人群相似。平均随访12.75±0.9个月。双侧角膜SEI记录为80%。在12个月的随访中,Te-PTK和他克莫司组的平均BCVA均有所改善,而对照组无明显变化。前部的平均角膜密度测定,中央,Te-PTK和他克莫司组的总角膜明显减少。Te-PTK和他克莫司组的HO-RMS和总RMS显着降低。BCVA,角膜密度测定(前,中央,和总角膜),和角膜像差(完全昏迷,总三叶形,HO-RMS,Te-PTK组和他克莫司组的总RMS)值明显优于对照组。Te-PTK组和他克莫司组之间在BCVA方面没有统计学上的显著差异,角膜密度测定法,角膜HOA,和角膜SEIs的持久性。Te-PTK和他克莫司组的角膜SEIs持久性明显低于对照组。
结论:Te-PTK和外用他克莫司是治疗腺病毒角膜SEIs提高视力的有效方法,角膜密度测定法,和角膜HOA。Pentacam的密度测定程序可以为腺病毒角膜SEIs的治疗提供客观指导。
背景:ClinicalTrials.govID为NCT04267991。
OBJECTIVE: To compare the changes in the measurement of corneal densitometry and total corneal higher-order aberrations (HOAs) between topical tacrolimus and transepithelial phototherapeutic
keratectomy (Te-PTK) in the treatment of adenoviral corneal subepithelial infiltrates (SEIs).
METHODS: This is an interventional prospective randomized
study, including 63 eyes of 35 patients with symptomatic adenoviral corneal SEIs for at least 6 months. All patients underwent previous topical steroid therapy associated with unsatisfactory response and/or complications. Patients were assigned into three groups: (1) Te-PTK group: Te-PTK with MMC 0.02% was performed by a Technolas; Teneo excimer laser; (2) tacrolimus group: tacrolimus 0.03% ointment was applied once daily for 2-6 months; the endpoint of treatment was based on the improvement in the corneal densitometry, BCVA, and OSDI; and (3) control group: no intervention was done. BCVA, corneal densitometry, and total corneal higher-order aberrations (HOAs) evaluation using Pentacam HR were done at the baseline, 1 week, and then 1, 3, 6, and 12 months of the
study.
RESULTS: The
study population was similar between all groups. The mean follow-up was 12.75 ± 0.9 months. Bilateral corneal SEI was recorded at 80%. At 12-month follow-ups, the mean BCVA improved in both the Te-PTK and tacrolimus groups without significant changes in the control group. The mean corneal densitometry of the anterior, central, and total cornea decreased significantly in the Te-PTK and tacrolimus groups. HO-RMS and total RMS decreased significantly in the Te-PTK and tacrolimus groups. BCVA, corneal densitometry (anterior, central, and total cornea), and corneal aberrations (total coma, total trefoil, HO-RMS, and total RMS) values were significantly better for the Te-PTK and tacrolimus groups than the control group. There were no statistically significant differences between Te-PTK and tacrolimus groups in terms of BCVA, corneal densitometry, corneal HOA, and the persistence of corneal SEIs. The persistence of corneal SEIs was significantly lower in Te-PTK and tacrolimus groups than the control group.
CONCLUSIONS: Te-PTK and topical tacrolimus are effective methods for the treatment of adenoviral corneal SEIs improving visual acuity, corneal densitometry, and corneal HOA. The densitometry program of the Pentacam may give an objective guide for the treatment of adenoviral corneal SEIs.
BACKGROUND: ClinicalTrials.gov ID is NCT04267991.