Clinical Trial of Laser Custom Corneal Collagen Cross-Linking in Keratoconus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Improvement in best spectacle-corrected visual acuity after laser custom CXL
研究概览
简要总结
Optical Coherence Tomography (OCT) devices are non-contact instruments that can measure the depth of scars, other causes of cloudiness of the cornea, and degree of corneal thinning in patients with keratoconus. Laser Custom Corneal Collagen Cross-linking (CXL) significantly decreases corneal aberrations and improves vision. This study will use OCT-guided setting for the lasers used in the corneal smoothing portion of the laser custom CXL procedure to assess the affect on visual outcomes.
详细描述
In the U.S., CXL and topography-guided laser ablation were approved independently, but not together. Another variation in technique involves the use of mitomycin-C (MMC), which is effective in reducing corneal haze after the laser surface ablation. Use of MMC during the laser custom CXL was associated with better outcomes, but in separate trials that could not be directly compared. This study will use OCT measurements to evaluate the magnitudes of direct and indirect laser actions after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosis of keratoconus
- •Minimum corneal thickness of 410 microns
排除标准
- •Inability to maintain fixation for OCT imaging
- •Inability to commit to required study visits
- •Inability to give informed consent
- •Eyes with concurrent retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery
- •Mature cataracts if found to limit visual potential to worse than 20/40
结局指标
主要结局
Improvement in best spectacle-corrected visual acuity after laser custom CXL
时间窗: 6 months after the CXL procedure
The primary goal of the trial is to determine the extent of visual improvement after laser custom CXL compared to preoperative measurements. Vision will be checked at various time points, but the primary time point will be 6-months post-procedure.
次要结局
- Determine CXL demarcation line depth(1 month after the CXL procedure)
研究者
David Huang
Peterson Professor of Ophthalmology & Professor of Biomedical Engineering
Oregon Health and Science University