Pocket Versus Tunnel Intrastromal Corneal Ring Segment Implantation (KeraRing) for the Management of Central Keratoconus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Complications
研究概览
简要总结
Keratoconus is a corneal degenerative disease associated with loss of best-corrected visual acuity. The use of intrastromal corneal ring segment implants is indicated to regularize the cornea and to reduce aberrations.
详细描述
Keratoconus is a corneal degenerative disease characterized by corneal thinning and subsequent development of irregular astigmatism, diminution of vision and loss of best-corrected visual acuity.
Management of keratoconus includes halting disease progression through a corneal strengthening procedure called corneal collagen cross-linking (CXL) which usually results in stabilizing the condition but with no improvement in visual acuity or quality. Intrastromal corneal ring segment (ICRS) implantation is a well-established procedure for the management of moderate keratoconus with a corneal flattening effect that is associated with improvement of visual acuity and reduction of optical aberrations.
The aim of the study is to evaluate and compare the visual, refractive and topographic outcomes of two different femtosecond laser assisted surgical techniques to create a corneal stromal pocket or a tunnel for implantation of ICRS for the management of central 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with progressive keratoconus with maximum keratometry (Kmax) between 50-65 diopters
- •Central keratoconus (Keratoconus with steepest corneal point within the central 3 mm zone).
- •Clear corneal with a minimum pachymetry of 400 μm.
排除标准
- •Corneal scars
- •Patients with advanced keratoconus with Kmax > 65 diopters.
- •Non-central keratoconus (para-central or peripheral keratoconus with steepest corneal point outside the central 3 mm zone).
- •Previous corneal cross-linking and/or ocular surgery.
- •Systemic diseases such as diabetes mellitus and autoimmune diseases
结局指标
主要结局
Complications
时间窗: 12 months
Postoperative complications following intrastromal corneal ring segment implantation.
Postoperative keratometry
时间窗: 12 months
Postoperative keratometry as measured by Scheimpflug imaging Pentacam
Postoperative Refraction
时间窗: 12 months
Spherical equivalent refraction measured by Topcon Auto-Keratorefractometer
Corrected distance visual acuity (CDVA)
时间窗: 12 months
Corrected distance visual acuity measurement using Snellen's Acuity Chart expressed as logMAR notation
Uncorrected distance visual acuity (UDVA)
时间窗: 12 months
Uncorrected distance visual acuity measurement using Snellen's Acuity Chart expressed as logMAR notation
次要结局
未报告次要终点
研究者
Mahmoud Abdel-Radi
Principal Investigator
Assiut University