A prospective clinical Study to evaluate the Safety and Efficacy of two different 0.1% Riboflavin used in Corneal Cross-linking treatment for patients with Keratoconus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- •Progression of Keratoconus [Time Frame: Pre-operative visit, 1,3, 6 & 12 Months Follow-up]
研究概览
简要总结
This is a prospective, comparative, open label, clinical study aimed to evaluate the safety and efficay of two different 0.1% Riboflavin solutions used in corneal cross-linking treatment for patients with keratoconus.
Flavin Isotonic Riboflavin Ophthalmic Solution 0.1%- Flavin (Biotech Ophthalmics Pvt. Ltd., India) will be compared with Peschke® D Standard Riboflavin Solution (PESCHKE Trade GmbH, Switzerland). 100 Eyes of patients with unilateral or bilateral keratoconus will be randomized to receive treatment with either Flavin or Peschke isotonic riboflavin 0.1% solutions, with 50 eyes in each group.
Post operative follow up will be conducted at 1,3, 6 & 12 Months and the clinical parameters evaluated between the two groups will be - uncorrected and best corrected visual acuity, refraction, change in keratometry and corneal thickness & endothelial cell count. Any adverse effects or post operative complications such as haze, corneal oedema, infection etc, will be immediately reported to ethics committee and necessary steps will be taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Unilateral/bilateral 2.A diagnosis of keratoconus.
- •3.Progressing keratoconus.
- •4.Patients with Keratometric readings ≤ 55 D 5.Patients ≥ 18 years of age 6.Patients with clear central cornea, without apical scarring.
- •7.Patients with corneal thickness ≥ 400 microns at the thinnest point.
- •8.Patient willing to participate and sign informed consent 9.Patient willing to come for all post-operative follow-up procedures as defined in study protocol.
排除标准
- •1.Eyes classified as either normal, atypical normal (except corneal ectasia), or keratoconus suspect on the severity grading scheme.
- •2.A history of previous corneal surgery or the insertion of intrastromal ring implantation in the eye(s) to be treated.
- •3.Previous corneal or Intraocular surgery 4.Pellucid marginal corneal degeneration 5.Eyes which are aphakic or pseudophakic and do not have a UV blocking lens implanted.
- •6.A history of delayed epithelial healing.
- •7.Patients with nystagmus or any other condition that would have prevented a steady gaze during the CXL treatment or other diagnostic tests.
- •8.Pregnancy & Lactation 9.Concurrent participation in another drug or device Study.
结局指标
主要结局
•Progression of Keratoconus [Time Frame: Pre-operative visit, 1,3, 6 & 12 Months Follow-up]
时间窗: Pre-operative visit, 1,3, 6 & 12 Months Follow-up
•Best Corrected Visual acuity [Time Frame: Pre-operative visit, 1,3, 6 & 12 Months Follow-up]
时间窗: Pre-operative visit, 1,3, 6 & 12 Months Follow-up
Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
时间窗: Pre-operative visit, 1,3, 6 & 12 Months Follow-up
•Endothelial Cell Count [Time Frame: Pre-operative visit, 1,3, 6 & 12 Months Follow-up]
时间窗: Pre-operative visit, 1,3, 6 & 12 Months Follow-up
As measured by Specular Microscope
时间窗: Pre-operative visit, 1,3, 6 & 12 Months Follow-up
次要结局
- Refraction(Corneal Demarcation Line Depth (DLD))