Eyecos Clinic, Tuset, 23-25, 08006, Barcelona, Spain.
Int Ophthalmol. 2021 Apr;41(4):1381-1393. doi: 10.1007/s10792-021-01693-5. Epub 2021 Jan 23.
To evaluate photoablative cosmetic iridoplasty (PCI), and its efficacy, safety, predictability, and satisfaction with the 532 nm Crystal Q-switched Nd: Yag laser, with 3-4 ns pulses, for depigmentation of the anterior epithelium of the iris in cases of heterochromia, nevus, or cosmetic indications (eye color change).
Prospective clinical study on efficacy, safety, predictability, and satisfaction.
The selection of patients was carried out in healthy individuals, over 18 years of age, with iris heterochromia (congenital-7% or acquired, secondary to topical medication-1%, trauma-0.5% or surgery-0.25%), nevus-0.25% and cosmetic cases-91%. Data were collected independently by assistant optometrists and classified in database. Excel statistical program was used to perform a general descriptive study, calculation of correlation factors, and statistical significance analysis between quantitative variables (Student T Test). PCI was performed in 1176 eyes of 588 patients. The procedures were planned in 2-3 phases of 4 consecutive sessions spaced 4-6 months apart. The IRÎZ (Eyecos) scanner was used to evaluate the cases, with photography, optical coherence tomography, and pneumotonography modules, along with the following software programs: Predictor, Simulator 3D, Analyzer and Planner (Eyecos).
This study began in 2012, so far 9 years of follow-up, to compare and choose the most suitable among 4 types of lasers to perform cosmetic iridoplasty. Finally, after 5 years, the Crystal Q-switched Nd: Yag at double frequency (532 nm) with 3-4 ns pulses demonstrated the highest efficacy, safety and predictability, so since early 2017 only this equipment has been used. Significant differences were found after 5-year follow-up between 1064, 532, 577 and 532/3-4 ns p = 0.09172, 0.06377 and 0.10183. From 9 January 2017 to 28 February 2020, 1176 eyes have been treated in 588 patients, with a mean age of 33.7 years (SD = 9.68 years, range = 18-70 years). 46.2% were male, and 53.7% were female. The efficacy, as quantified with the Analyzer comparison software, was nearly 87-95%. There were no significant differences in corrected vision (9 years total follow-up p = 0.78235; last 4 years FU p = 0.99999) and ocular pressure (9 years total FU p = 0.68251; last 4 years FU p = 0.63204) before and after the procedure. The only notable complications (25%) were delayed and brief iritis, which were self-limited with routine topical treatment. The predictability was 80-90%. In the lightest-colored eyes, turquoise blue colors were obtained as a rule, in varying brightness; and in the darkest ones, gray blue tones of varying lightness. The patients' subjective satisfaction at the end of treatment was 95%.
After 9 years of uninterrupted follow-up, PCI has demonstrated a high effectiveness to selectively depigment superficial melanin of iris, with a high predictability and patient satisfaction, without remarkable long-term complications. Only for a week, appropriate pre- and postoperative medication was necessary to guarantee the absence of discomfort, thus confirming security. PCI is effective, safe, and predictable for the treatment of pigmentary disorders in the iris and for the elective cosmetic indications in eye color change.
评估 532nm 倍频 Q-开关 Nd:YAG 激光(Crystal Q-switched Nd: Yag)的光消融性美容性虹膜成形术(PCI)的疗效、安全性、可预测性和患者满意度,该激光的脉冲为 3-4ns,用于去除虹膜前上皮的色素,适用于虹膜异色症、色素痣或美容(改变眼睛颜色)等情况。
针对疗效、安全性、可预测性和满意度的前瞻性临床研究。
选择年龄在 18 岁以上的健康个体,患有虹膜异色症(先天性 7%或后天性,因局部用药引起的 1%、创伤 0.5%或手术 0.25%)、色素痣(0.25%)和美容病例(91%)。由助理验光师独立收集数据,并将其分类到数据库中。使用 Excel 统计程序进行一般描述性研究,计算相关因素,并对定量变量(Student T 检验)进行统计显著性分析。对 588 例患者的 1176 只眼进行了 PCI 治疗。手术计划分 2-3 个阶段进行,每个阶段间隔 4-6 个月,共进行 4 次。使用 IRÎZ(Eyecos)扫描仪评估病例,并配备摄影、光学相干断层扫描和眼压计模块,以及以下软件程序:Predictor、Simulator 3D、Analyzer 和 Planner(Eyecos)。
本研究始于 2012 年,目前已进行了 9 年的随访,以比较和选择 4 种激光中最适合的一种进行美容性虹膜成形术。最终,经过 5 年的时间,双频(532nm)的 Q-开关 Nd:YAG 激光显示出最高的疗效、安全性和可预测性,因此自 2017 年初以来,仅使用该设备。5 年随访后,1064nm、532nm、577nm 和 532/3-4ns 之间的差异有统计学意义(p=0.09172、0.06377 和 0.10183)。自 2017 年 1 月 9 日至 2020 年 2 月 28 日,对 588 例患者的 1176 只眼进行了治疗,患者平均年龄为 33.7 岁(标准差=9.68 岁,范围 18-70 岁)。男性占 46.2%,女性占 53.7%。通过 Analyzer 比较软件量化的疗效接近 87-95%。校正视力(9 年总随访 p=0.78235;最后 4 年 FU p=0.99999)和眼压(9 年总 FU p=0.68251;最后 4 年 FU p=0.63204)在治疗前后无显著差异。唯一值得注意的并发症(25%)是延迟和短暂的虹膜炎,经常规局部治疗后可自行缓解。可预测性为 80-90%。在颜色最浅的眼睛中,通常会获得绿松石蓝色,亮度不同;而在颜色最深的眼睛中,会获得不同亮度的灰蓝色调。治疗结束时患者的主观满意度为 95%。
经过 9 年的不间断随访,PCI 已被证明是一种有效的方法,可以选择性地去除虹膜前上皮的黑色素,具有较高的可预测性和患者满意度,且无明显的长期并发症。仅需在治疗前后一周内适当使用药物,以确保无不适,从而证实其安全性。PCI 对于虹膜色素沉着障碍和眼睛颜色改变的美容性选择治疗是有效、安全和可预测的。