To study the clinical & biomechanical outcomes of collagen crosslinking using adjusted fluency in progressive keratoconus with thin cornea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To compare clinical outcomes using adjusted fluency vs standard hypo-osmolar Collagen Crosslinking in Progressive Keratoconus Ectasia stabilization by
研究概览
简要总结
Study Title To study the clinical & biomechanical outcomes of collagen crosslinking using adjusted fluency in progressive keratoconus with thin cornea.
• Keratoconus is a progressive bilateral corneal ectatic dystrophy with irregular stromal thinning, resulting in a cone-like protrusion and significant vision loss.
• In corneal collagen cross linking we use
1. Riboflavin 0.1 percent drops isotonic or hypotonic
2. Ultraviolet A 365 nm wavelength
• The standard protocol uses 3 milliwatt per cm squareintensity for 30 mins duration.
• The accelerated protocol uses 9 milliwatt per cm square intensity for 10 mins duration.
• The energy produced remains constant in both protocols at 5.4 Joule per cm square.
The above mentioned conventional & hypotonic protocol does not include patients with corneal thickness of less than 400 microns i.e. thin cornea. Other protocols for thin cornea are not as effective as standard protocol & give less predictable results.
We will be using the adjusted fluency protocol which is designed especially for patients with thin cornea. It achieves arrest of keratoconus & matches the international safety standards of the conventional protocols.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 10.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Keratoconus Patient from Age 10 to 30yrs Primary Keratoconus Thin corneas (Corneal pachymetry at thinnest point less than 400 microns).
排除标准
- •Not willing for C3R surgery Endothelial disorder Prior herpetic infection/Concurrent infection/Inflammation Pre-existing ocular trauma Severe corneal scarring or opacification Pregnant and nursing mother Previous intraocular and corneal surgery Glaucoma Hormonal Therapy.
结局指标
主要结局
To compare clinical outcomes using adjusted fluency vs standard hypo-osmolar Collagen Crosslinking in Progressive Keratoconus Ectasia stabilization by
时间窗: Preop (baseline), Post op Day 5, Post op 1 Month,Post op 3 Month, Post op 6 Month, Post op 12 Month
1. Serial Tomography evaluation
时间窗: Preop (baseline), Post op Day 5, Post op 1 Month,Post op 3 Month, Post op 6 Month, Post op 12 Month
2.Serial Corneal Biomechanical Profile evaluation using Corvis ST
时间窗: Preop (baseline), Post op Day 5, Post op 1 Month,Post op 3 Month, Post op 6 Month, Post op 12 Month
次要结局
- 1. Endothelial Status using Specular Microscopy
研究者
Dr. Pallavi Joshi
Dept. of Cornea & Refractive Surgery