Collagen Crosslinking for Keratoconus - a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Kmax
研究概览
简要总结
The purpose of this study is to determine whether corneal collagen crosslinking is effective in the treatment of progressive keratoconus.
详细描述
Keratoconus is a noninflammatory, asymmetrical, progressive corneal ectasia caused by biomechanical instability of the corneal stroma. Treatment modalities are primarily glasses or contact lenses. It has been estimated that one out of five patients will progress to such an extent that a corneal transplant is necessary to regain useful vision.
Corneal collagen crosslinking (CXL) is a treatment modality that intends to halt progression of keratoconus. This study investigates the efficacy av CXL in stabilizing the cornea in keratoconus by means of a randomized controlled clinical trial.
Participants are eligible for inclusion if progressive keratoconus is confirmed and the inclusion criteria are met. Follow-up after inclusion is at 1 week (treatment group), 1, 3, 6 and 12 months. Pre- and post-inclusion examinations include measurement of uncorrected distance visual acuity (UCDVA), best spectacle corrected distance visual acuity (BSCDVA), Scheimpflug-topography and slitlamp examination.
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
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Keratoconus diagnosis determined clinically and topographically (KISA%- index)
- •Significant progression is defined as change (increase) of Kmax by at least
- •1D from baseline at 6 months and/or change (increase) of Sim-K-ast by at least 1D from baseline at 6 months. Kmax is defined as the steepest radius of curvature (either the maximum simulated K-reading or the maximum K-reading in the 3-mm zone or the 5-mm zone) of the anterior corneal surface that progressed the most during 6 months observation
- •Ability to stop contact lens (rigid and soft) wear at least two weeks prior to next exam
- •Signed written informed consent
排除标准
- •Age < 18 years
- •Pregnancy
- •Breast feeding
- •History of corneal surgery
- •History of ocular herpes simplex infection
- •Minimal corneal thickness < 300 micrometers
- •Recurrent corneal erosions
- •Other corneal (e g endothelial) or conjunktival diseases
- •Neurodermatitis
- •Severe forms av atopic disease
- •Collagenoses, autoimmune or other systemic disease
- •Systemic treatment with high doses of steroids
- •Severe scarring och striae of the cornea
- •Relative exclusion criteria:
- •Kmax > 58D
- •Minimal corneal thickness < 400 micrometers (a modified CXL-treatment will be used swelling the cornea before UV-illumination treatment).
研究组 & 干预措施
Corneal Collagen Crosslinking
The keratokonic eye which progresses most is included and randomized. Significant progression is defined in the eligibility criteria section. If randomized to the treatment arm the cornea is treated with collagen crosslinking as described below.
干预措施: Corneal Collagen Crosslinking (Device)
Control group
The keratokonic eye which progresses most is included and randomized to either the treatment group (CXL) or the control group.
结局指标
主要结局
Kmax
时间窗: 12 months
Kmax is defined as the steepest radius of curvature of the anterior corneal surface. It is measured by Scheimpflug-topography (Pentacam, Oculus Inc.). An increase of less than 1 diopter (D) from baseline at 12 months is defined as non-progression.
次要结局
- Sim-K-astigmatism(12 months)
- UCDVA(12 months)
- BSCDVA(12 months)
- MRSE(12 months)
研究者
Wolf K Wonneberger, MD
Ophthalmologist, Cornea and External Diseases Team
Sahlgrenska University Hospital