Comparison of efficacy and efficiency of continuous v/s pulsed modes of corneal collagen cross linking in keratoconus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare the efficacy and safety of continuous and pulsed mode of corneal collagen cross linking for keratoconus patients.
研究概览
简要总结
After topical anesthesia, the corneal epithelium is scraped. A drop of riboflavin 0.25% dextran solution is applied every 2 minutes for 10 minutes.For 25 eyes of 25 patients, exposure to UV light (365 nm, 30 mW/cm2) for 3 minutes using the KXL® system (Avedro, Inc.) was done. .For the other 25 eyes of 25 patients, exposure to UV light (365 nm, 30 mW/cm2) for 6minutes (1.5 sec on 1.5 sec off) using the KXL® system (Avedro, Inc.) was done. Later, patient follow up is done at 1, 3, 6months and results are compared using the following-
- ORBSCAN- For evaluation of
K max
K steep
K flat
- PENTACAM - For evaluation of
K max (ant and post)
K steep (ant and post)
K flat (ant and post)
Corneal volume
Pachymetry (apex and thinnest)
-
AS-OCT – For evaluation of depth of demarcation line.
-
CORVIS ST – to evaluate
Pachymetry
Deflection amplitude
Applanation time 1 and 2
Applanation length 1 and 2
Applanation velocity 1 and 2
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 10.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients giving written informed consent.
- •2.Patients within age group of 10-40yrs.
- •3.Patients with progressive keratoconus.
- •4.Patients with pre-operative corneal thickness measured with pachymetry of more than 400microns.
排除标准
- •1.corneal pachymetry less than 400 microns 2.decompensated cornea 3.corneal dystrophies 4.age> 40years and <10 years 5.pre-existing scar 6.severe dry eye 7.eyes with limbal stem cell deficiency.
- •8.corneal ectasia other thankeratoconus.
- •9.active ocular surface disorder.
结局指标
主要结局
To compare the efficacy and safety of continuous and pulsed mode of corneal collagen cross linking for keratoconus patients.
时间窗: Relevant data will be collected preoperatively , at 1, 3, 6 months postoperatively.
次要结局
- 1. Pre operative and post operative Uncorrected and best corrected visual acuity(2. Pre operative and post operative changes in corneal parameters)