Internatioa Vision Correction Research Centre, Department of Ophthalmology, University of Heidelberg, Germany.
J Refract Surg. 2012 Mar;28(3):182-8. doi: 10.3928/1081597X-20120203-01.
To investigate functional outcomes of the INTRACOR femtosecond laser-based intrastromal procedure to treat presbyopia.
Sixty-three eyes from 63 presbyopic patients (median age: 54 years) with mild hyperopia were enrolled in this prospective, ethics committee-approved, multi-center, nonrandomized clinical trial. The INTRACOR procedure was performed using the Technolas femtosecond laser (Technolas Perfect Vision GmbH) in the nondominant eye. Postoperatively, follow-up was performed at 1 day, 1 week, and 1, 3, 6, and 12 months and included near and distance visual acuity tests, slit-lamp examinations, and corneal topography.
All 63 surgeries were uneventful. Twelve months postoperatively, outcomes of 58 (92.1%) eyes were available for evaluation. Median uncorrected distance visual acuity (0.1 logMAR [range: 0.5 to 0.0 preoperatively and 0.5 to -0.1 postoperatively]) and corrected distance visual acuity (CDVA) (0.0 logMAR [range: 0.2 to -0.2 preoperatively and 0.3 to -0.1 postoperatively]) remained stable. Median spherical equivalent changed from +0.63 diopters (D) preoperatively to 0.00 D postoperatively. Median uncorrected near visual acuity increased significantly from 0.7 logMAR (range: 1.0 to 0.2) preoperatively to 0.2 logMAR (range: 0.8 to -0.1) postoperatively and eyes gained a median of 4 lines (range: 1 to 9 lines). Losses of 2 lines of CDVA were noted in 7.1% of eyes. Ring cuts were faintly visible at 12 months.
The INTRACOR presbyopia procedure showed good and stable visual acuity outcomes over 12-month follow-up but loss of CDVA occurred in 7% of eyes. Overall patient satisfaction with the procedure was approximately 80%. Short treatment time and maintained corneal surface integrity are advantages of this procedure.
研究基于 INTRACOR 飞秒激光的基质内程序治疗远视的功能结果。
本前瞻性、伦理委员会批准的多中心、非随机临床试验纳入了 63 名(中位年龄:54 岁)患有轻度远视的远视患者的 63 只眼。在非优势眼使用 Technolas 飞秒激光(Technolas Perfect Vision GmbH)进行 INTRACOR 手术。术后 1 天、1 周、1、3、6 和 12 个月进行随访,包括近视力和远视力测试、裂隙灯检查和角膜地形图。
所有 63 例手术均顺利完成。12 个月后,58 只(92.1%)眼的结果可用于评估。中位未矫正远视力(0.1 logMAR [术前范围:0.5 至 0.0,术后范围:0.5 至 -0.1])和矫正远视力(CDVA)(0.0 logMAR [术前范围:0.2 至 -0.2,术后范围:0.3 至 -0.1])保持稳定。中位球镜等效术前从+0.63 屈光度(D)变为术后 0.00 D。中位未矫正近视力显著从术前 0.7 logMAR(范围:1.0 至 0.2)增加至术后 0.2 logMAR(范围:0.8 至 -0.1),并且眼平均增加 4 行(范围:1 至 9 行)。7.1%的眼出现 CDVA 丧失 2 行。12 个月时可隐约看到环形切口。
INTRACOR 远视手术在 12 个月的随访中显示出良好且稳定的视力结果,但 7%的眼出现 CDVA 丧失。患者对该手术的总体满意度约为 80%。该手术的优点是治疗时间短且保持角膜表面完整性。