A Randomized Study of Clinical and Structural Outcome of Corneal Collagen Crosslinking (CXL) With Conventional Versus Accelerated Ultraviolet-A Irradiation Using Riboflavin With Hydroxypropyl Methylcellulose (HPMC).
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 主要终点
- Compare change in maximum corneal curvature, visual acuity, endothelial cell density and depth of cross-linking in CXL with conventional versus accelerated UVA irradiation.
研究概览
简要总结
Compare different corneal parameters and visual outcome of corneal collagen cross-linking (CXL) with conventional versus accelerated ultraviolet-A irradiation using riboflavin with hydroxypropyl methylcellulose.
详细描述
40 patients with signs of progressive keratoconus are randomized to either corneal collagen cross-linking (CXL) with conventional ultraviolet-A (UVA) irradiation at 3 milliwatt/cm² (mW/ cm²) or accelerated ultraviolet-A (UVA) irradiation at 9 mW/ cm². In both groups riboflavin with hydroxypropyl methylcellulose was used. The objectives of this study are to evaluate and compare different corneal parameters (maximum corneal curvature, depth of collagen cross-linking, endothelial cell density) and clinical outcomes of uncorrected visual acuity (UCVA) and best spectacle corrected visual acuity (BSCVA)) after CXL with conventional and accelerated UVA irradiation.
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
- •Patients with increase of minimum of 1,0 diopter in maximum keratometry.
- •Patients with increase in corneal astigmatism of minimum 1,0 diopter.
- •Patients with in spherical equivalent of min 0,5 diopter.
- •Patients living in Eastern Norway.
排除标准
- •Minimum pachymetric corneal thickness (Pentacam)<360 µm.
- •Central corneal scar.
- •Chemical burn, serious corneal infections and ocular surface diseases.
- •Pregnancy.
- •Lactation.
研究组 & 干预措施
Treatment group A
Corneal collagen cross-linking using riboflavin with hydroxypropyl methylcellulose solution and ultraviolet-A (UVA) irradiation at 3 milliwatt/cm² (mW/cm²) for 30 minutes.
Device: UV-X 1000 irradiator (3 mW/cm²) Drug: riboflavin with hydroxypropyl methylcellulose
干预措施: UV-X 1000 (3 mW/cm²) (Device)
Treatment group A
Corneal collagen cross-linking using riboflavin with hydroxypropyl methylcellulose solution and ultraviolet-A (UVA) irradiation at 3 milliwatt/cm² (mW/cm²) for 30 minutes.
Device: UV-X 1000 irradiator (3 mW/cm²) Drug: riboflavin with hydroxypropyl methylcellulose
干预措施: riboflavin with hydroxypropyl methylcellulose (Drug)
Treatment group B
Corneal collagen cross-linking using riboflavin with hydroxypropyl methylcellulose solution and ultraviolet-A (UVA) irradiation at 9 mW/cm² for 10 minutes.
Device: UV-X 2000 irradiator (9 mW/cm²) Drug: riboflavin with hydroxypropyl methylcellulose
干预措施: UV-X 2000 (9 mW/cm²) (Procedure)
Treatment group B
Corneal collagen cross-linking using riboflavin with hydroxypropyl methylcellulose solution and ultraviolet-A (UVA) irradiation at 9 mW/cm² for 10 minutes.
Device: UV-X 2000 irradiator (9 mW/cm²) Drug: riboflavin with hydroxypropyl methylcellulose
干预措施: riboflavin with hydroxypropyl methylcellulose (Drug)
结局指标
主要结局
Compare change in maximum corneal curvature, visual acuity, endothelial cell density and depth of cross-linking in CXL with conventional versus accelerated UVA irradiation.
时间窗: 2 years
Compare change in maximum corneal curvature (Kmax; diopter), uncorrected visual acuity (UCVA, logMAR), best spectacle corrected visual acuity (BSCVA, logMAR) from baseline and depth in micrometer(µm) of corneal collagen cross-linking on anterior segment optical coherence tomography and confocal microscopy in corneal collagen cross-linking with conventional at 3 milliwatt/cm² (mW/cm²) versus accelerated (9 mW/cm²) ultraviolet-A irradiation using riboflavin with hydroxypropyl methylcellulose.
次要结局
- Compare depth of corneal collagen cross-linking on anterior segment optical coherence tomography and confocal microscopy with change in endothelial cell density in CXL with conventional versus accelerated ultraviolet-A irradiation.(2 years)
- Compare depth of corneal collagen cross-linking on anterior segment optical coherence tomography and confocal microscopy with change in maximal corneal curvature (Kmax) and visual acuity in CXL with conventional versus accelerated UVA irradiation.(2 years)
研究者
Anne Marie Hagem
MD
Oslo University Hospital