Moawad Ehab M, Abd Elghany Ahmed A, Gab-Alla Amr A, Elbassiouny Osama M, Badawy Mohsen S
Department of ophthalmology, Faculty of Medicine Suez Canal University, Ismailia, Egypt.
BMC Ophthalmol. 2019 Apr 23;19(1):93. doi: 10.1186/s12886-019-1100-7.
The study aimed to assess the role of intraoperative mitomycin-C (MMC) application during hyperopic LASIK correction (+ 1.00 D to + 6.00 D) by examining topographic corneal changes and incidence of regression over a one-year follow-up period.
This comparative randomized control study included 68 hyperopic patients (136 eyes) divided into two groups; Group A included 34 patients (68 eyes) that had LASIK with the application of 0.02% MMC for 10 s on the stromal bed after excimer laser treatment, and group B included 34 patients (68 eyes) that had LASIK without MMC application. Uncorrected distance visual acuity (UDVA), refraction, keratometry and topography were recorded at 1st week and 1st, 3rd, 6th, and 12th months postoperation. Predictability and treatment efficacy were also recorded at the end of the follow-up period.
Better predictability was noted in group A than in group B at the 6 month and 12 month follow-up visits, with a mean cycloplegic refraction SE of + 0.5 ± 0.31 D in group A and + 0.67 ± 0.39 D in group B at the 6 month visit, and + 0.63 ± 0.37 D in group A and + 0.89 ± 0.48 D in group B at the 12 month visit. The efficacy of the treatment at the end of the follow up period was better in group A than in group B. Group A showed fewer topographic corneal changes than group B.
Intraoperative MMC application during hyperopic LASIK achieves better predictability and efficacy and induces fewer topographic changes and lower regression rate of hyperopia during the first postoperative year.
the Pan African Clinical Trial Registry PACTR201901543722087 , on 29 January 2019.
本研究旨在通过检查地形图角膜变化及一年随访期内的回退发生率,评估术中应用丝裂霉素C(MMC)在远视性准分子激光原位角膜磨镶术(LASIK)矫正(+1.00 D至+6.00 D)中的作用。
这项比较性随机对照研究纳入了68例远视患者(136只眼),分为两组;A组包括34例患者(68只眼),在准分子激光治疗后于基质床应用0.02%的MMC 10秒进行LASIK手术,B组包括34例患者(68只眼),进行未应用MMC的LASIK手术。在术后第1周以及术后第1、3、6和12个月记录裸眼远视力(UDVA)、屈光、角膜曲率和地形图。在随访期结束时还记录了可预测性和治疗效果。
在6个月和12个月的随访中,A组的可预测性优于B组,6个月随访时A组平均睫状肌麻痹验光球镜等效度(SE)为+0.5±0.31 D,B组为+0.67±0.39 D;12个月随访时A组为+0.63±0.37 D,B组为+0.89±0.48 D。随访期结束时A组的治疗效果优于B组。A组角膜地形图变化少于B组。
远视性LASIK术中应用MMC可获得更好的可预测性和疗效,在术后第一年引起更少的地形图变化和更低的远视回退率。
泛非临床试验注册中心PACTR201901543722087,2019年1月29日。