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临床试验/NCT05905978
NCT05905978尚未招募不适用

Effectiveness and Safety of Donors Predisposed by Corneal Collagen Cross-linking in Deep Lamellar Keratoplasty for Treating the Patients With Keratoconus,A Randomized Controlled Trial.

Zhongshan Ophthalmic Center, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年6月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
1
主要终点
Simulated keratometry

研究概览

简要总结

The Study was designed as a randomized controlled study with the following objectives:

To investigate whether use of donors predisposed by corneal collagen cross-linking (CXL) reduced myopic refractive errors for keratoconic eyes after Deep anterior lamellar keratoplasty (DALK).

Overall 70 patients are planned to recruit., the patients were assigned to CXL graft group, in which corneal donors predisposed by CXL were used, or the conventional graft group, in which corneal donors stored in corneal storage media were used. The patients will be followed-up for 24 months.

详细描述

Keratoconus is a progressive ecstatic corneal disease characterized by forward bulging of the cornea, thinning of the corneal stroma, and irregular astigmatism. Corneal transplantation is necessary for patients with advanced keratoconus when spectacles and contact lens are inadequate for visual correction. Deep anterior lamellar keratoplasty is a conventional procedure for the treatment of keratoconus. However, DALK itself frequently causes abnormality of refraction, such as high degrees of astigmatism owing to irregular corneal surface for keratoconic eyes. Possible mechanisms of this progressive astigmatism include the recurrence of keratoconus in the grafts, progressive corneal thinning of the host cornea, or progressive misalignment of the graft- host interface over time, which prevents the achievement of satisfactory vision.

Corneal collagen cross-linking is believed to have the ability to halt or decrease the progression of keratoconus. CXL treats keratoconus by strengthening corneal stromal collagen bonds with riboflavin activated by ultraviolet A (UVA), and is now a first-line treatment for progressive keratoconus. In this randomized controlled trial, we performed CXL on corneal donor tissues with the aim of achieving corneal stromal stiffening, thereafter DALK was conducted for the patients with advanced keratoconus using the tissues predisposed by CXL. The goal of this study is evaluating whether the strengthening grafts could reduce postoperative myopic refractive errors or arrest the progression of keratoconus for the patients with DALK.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1.The best corrected visual quality of frame glasses is less than 0.3,2.The best corrected visual quality of rigid gas permeable contact lens (RGPCL) is less than 0.5/ RGPCL intolerance,3.The anterior corneal surface curvature >55D,4.The thinnest corneal thickness is less than 400 μm. One of the above four items is met
  • Patients must be willing and able to return for scheduled follow-up examinations for 36 months after surgery
  • Ages:over 18 Years

排除标准

  • History of intraocular surgery
  • Severe dry eye
  • Severe eyelid and conjunctival scar
  • Loss of vision in contralateral eye
  • Pregnant and lactating women

结局指标

主要结局

Simulated keratometry

时间窗: up to 36 months

Simulated keratometry measured by topography

次要结局

  • Uncorrected distance visual acuity(UDVA)(36 months)
  • Corneal thickness(36 months)
  • Corneal endothelium cells(36 months)
  • Intraocular pressure(36 months)
  • Spherical equivalent (SE)(36 months)
  • Manifest cylinder(36 months)
  • Corrected distance visual acuity (CDVA)(36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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