Optical Quality of the Cornea in Orthokeratology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- OPTICAL QUALITY
研究概览
简要总结
Analyzing Optical Quality After the Use of Overnight Orthokeratology (Ortho-K)
详细描述
Optical Quality of the Cornea in Orthokeratology
Influence of changes in total corneal refractive power, corneal asphericity, and epithelial thickness.
Introduction:
The cornea is the transparent and avascular tissue of the eye, consisting of five layers: the corneal epithelium, Bowman's membrane, the stroma, Descemet's membrane, and the endothelium. Its thickness varies, being thinner at the central level, approximately 520 microns (0.52 mm), and about 1 mm near the sclera.
The corneal epithelium, the outermost layer, not only provides strong protective functions but also plays a role in corneal refractive function. In particular, the central corneal epithelium is especially important for corneal refraction. The refractive action of any optical surface is governed by two main parameters: the curvature of its surface and the difference in refractive indices of the media it separates.
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
盲法说明
Statistical Analysis
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between 8 and 21 years old. Those who accept to participate in the study. The use of Ortho-K lenses for 8 to 10 hours per night, once the risks and benefits of using Ortho-K have been explained.
- •Refractive error of myopia between -1.00 and -5.00 diopters (D) with astigmatism of 1.50 D or less, with-the-rule.
- •Best-corrected visual acuity of 20/20 or better before treatment.
- •Ortho-K lens centered or decentered by no more than 0.5 mm radially, determined by slit-lamp examination.
排除标准
- •History of hard contact lens use and contraindications for ocular and systemic Ortho-K, determined by a routine examination.
- •Patients who have previously undergone any refractive modulation procedure.
- •Patients with any corneal pathology, dry eye, glaucoma, retinal pathology, strabismus, ptosis, amblyopia, history of ocular allergy, or infection.
研究组 & 干预措施
Ortho - k
The Utilization of Otho-K Contact lenses
干预措施: Ortho-K (Device)
结局指标
主要结局
OPTICAL QUALITY
时间窗: 1 month after using Ortho-K
The primary outcome measure is the change in total corneal higher-order aberrations between baseline and 30 days of orthokeratology lens wear. It will be expressed using Zernike coefficients in microns.
次要结局
未报告次要终点
研究者
Jose Licari
Ophtalmologist Doctor
Institut Investigacio Sanitaria Pere Virgili