Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS: Results of a 2-year Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Topographical parameters
研究概览
简要总结
In the present study the investigators compare the clinical outcome corneal cross linking with either the stand-ard Dresden (sCXL) or the accelerated custom-fast (aCFXL) ultraviolet A irradiation protocol using riboflavin-D-α-Tocopheryl polyethyleneglycol1000 succinate for progressive keratoconus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •documented progressive keratoconus
- •changes in uncorrected distance visual acuity (UDVA) above 1.00 D
- •Corrected distance visual acuity (BCVA) above 1.00 D
- •spherical equivalent greater than 0.50 D
排除标准
- •Corneal pachymetry of less than 400 µm
- •less than 2000 cells/cm2,
- •corneal scarring,
- •nystagmus or any motility disorder that prevented a fixed gaze during the examination
- •Current contact lens use
研究组 & 干预措施
sCXL
Standard protocol of Dresden Riboflavin-VEPTGS solution applied every 2 mins during UV UVA fluence of 3mW/cm2 UVA Irradiation time 30 minutes
干预措施: Standard CXL (Other)
aCFXL
Accelerated custom fast CXL protocol. The protocol has been developed on a published mathematical model that takes into consideration objective variables such as the equation governing the UVA-induced riboflavin con-sumption rate and the corneal thickness at its thinnest point.
Riboflavin-VEPTGS solution: Epithelial lavage before UV UVA fluence of 1.8 ±0.9 mW/cm2 UVA Irradiation time 10 ± 1.5 minutes
干预措施: accelerated custom-fast CXL (Other)
结局指标
主要结局
Topographical parameters
时间窗: 2 years
Maximum keratometry: diopters Mean keratometry: diopters Minimum corneal tickness: diopters
次要结局
- Biomechanical parameters(2 years)
- Refractive parameters(2 years)
研究者
Ciro Caruso
MD, Head of Corneal Transplant Center
Corneal Transplant Center, Pellegrini Hospital