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临床试验/NCT03879421
NCT03879421Unknown不适用

The Role of Anterior Segment Optical Coherence Tomography in Evaluation of the Keratoconic Cornea After Corneal Collagen Cross Linking.

Reham Mahmoud Abdelrahman2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2016年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
44
试验地点
2
主要终点
Change in maximum keratometry (K-max) in diopters (D)

研究概览

简要总结

Aim of work:

  • To detect abnormal corneal thinning in keratoconus using pachymetry maps measured by high-speed anterior segment optical coherence tomography (OCT).
  • To evaluate the visualization and depth of the demarcation line with anterior segment optical coherence tomography (AS-OCT) after corneal collagen cross-linking (CXL).
  • To compare the depth of demarcation line between epithelial-on (Epi-on) and epithelial-off (Epi-off) corneal collagen cross-linking.

详细描述

Keratoconus is a bilateral, asymmetric, progressive, non-inflammatory corneal ectatic disorder that is characterized by progressive thinning, steepening and potential scaring. Usually it affects the inferior or central cornea that becomes thinner and bulges forward in a cone-shaped fashion, inducing irregular astigmatism and myopia and reducing the quality of vision. Approximately 50% of clinically normal fellow eyes will progress to KC within 16 years. The greatest risk is during the first 6 years of the onset.

Annual incidence of KC also varies greatly from 0.002% , to 0.23% of 100,000 population per year. Most of the western studies support the lower figure of 0.002% , while in the Middle-East it is about 0.02 per year. In the middle-East, there is about ten-fold higher incidence (0.02% compared to 0.002%), and ten-fold higher prevalence (2.34% compared to 0.23%), as compared to Western counries.

Management of keratoconus depends on a variety of factors including visual acuity, the degree of corneal thinning and steepening. Rigid gas permeable contact lenses (RGPs) have been tried to correct corneal irregularity and astigmatism in keratoconus but they don't stop keratoconus progression. Corneal collagen cross linking (CXL) is now considered as the treatment of choice in mild to moderate cases of keratoconus and is proven to halt the disease progression. The implantation of intrastromal corneal ring segments (e.g. INTACS, Ferrara & Keraring) has been indicated for cases with moderate keratoconus to flatten the steep irregular corneas. Advanced cases of keratoconus with marked deterioration of vision or corneal scarring may be good candidates for deep anterior lamellar or penetrating Keratoplasty (DALK or PKP).

Collagen cross-linking (CXL) is a relatively new conservative approach for progressive corneal ectasia, which is able to strengthen corneal tissue reforming new covalent bonds. This strategy is based on the underlying pathology of the disease. Corneal collagen cross linking (CXL) idea was based on the fact that a photosensitizer substance like riboflavin (vitamin B2) can interact with ultraviolet irradiation (Ultraviolet-A) to strengthen the corneal tissue inter and intrafibrillar collagen bonds thus preventing further thinning, corneal protrusion and reduces corneal irregular astigmatism.

Epithelial debridement enhances riboflavin corneal penetration that allows absorption of wide range of light spectrum wave lengths including ultra violet A.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 36 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with progressive keratoconus (maximum K-reading between 46 diopters and 56 diopters), clear cornea and corneal pachymetry > 380um.

排除标准

  • Corneal scarring.
  • Advanced keratoconus (k-max > 56 D).
  • Corneal pachymetry (thinnest location) < 380 µm.
  • Epithelial healing disorders e.g.
  • Recurrent corneal erosion syndrome.
  • History of diseases that may delay corneal healing or predispose the eye for future complications (e.g. rheumatic disorders, glaucoma, uveitis, chemical burn, corneal dystrophy).
  • History suggestive of herpetic keratitis because the UVR can activate herpes virus.
  • Post-LASIK ectasia and/or previous corneal surgeries e.g. intrastromal corneal ring segments (INTACS).
  • Pregnancy and breast-feeding.

研究组 & 干预措施

Group 1 (Epithelium-off accelerated CXL)

Active Comparator

patients with corneal thickness > 400 µm (thinnest location) were assigned into Epi-off accelerated CXL procedure

干预措施: Accelerated corneal collagen cross linking (Procedure)

Group 2 (Epithelium-on accelerated CXL)

Active Comparator

patients with corneal thickness > 380 µm and < 400 µm thinnest location) were assigned into Epi-on Trans-epithelial accelerated CXL procedure

干预措施: Accelerated corneal collagen cross linking (Procedure)

结局指标

主要结局

Change in maximum keratometry (K-max) in diopters (D)

时间窗: preoperative, 6 months and 12 months postoperative

to compare preoperative values of K-max with values at both 6 and 12 months follow up visits.

Demarcation line (DL) depth

时间窗: 3 months post corneal collagen cross linking

DL is a hyper-reflectivity seen in the anterior corneal stroma between the crossed and non-crossed collagen stromal bundles using anterior segment optical coherence tomography.

Change in central corneal thickness in (µm)

时间窗: preoperative, 6 months and 12 months postoperative

using anterior segment OCT

次要结局

  • Change in the mean refractive spherical equivalent (MRSE)(preoperative, 6 months and 12 months postoperative)
  • Change in pachymetry at the thinnest location(preoperative, 6 months and 12 months postoperative)
  • Change in visual acuity(preoperative, 6 months and 12 months postoperative)

研究者

发起方
Reham Mahmoud Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Reham Mahmoud Abdelrahman

Principal Investigator

Assiut University

研究点 (2)

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