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临床试验/NCT05476042
NCT05476042Unknown2 期

The Effect of Local Erythropoietin 3000 and 6000 Units on the Treatment of Conjunctival and Scleral Avascular Lesions: A Multicenter Clinical Trial

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年8月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
60
试验地点
1
主要终点
The size of the conjunctival epithelial defect

研究概览

简要总结

Patients with acute avascular lesions of the conjunctiva and sclera will be included in the study. Patients will undergo a complete eye examination including a slit lamp, intraocular pressure measurement, and fundoscopy with dilated pupil. At the same time, laboratory examination including measurement of fasting blood sugar (FBS) level, complete blood count (CBC) and systemic blood pressure will be performed. Patients will be randomly divided into three groups. The groups will receive sham drops (normal saline), erythropoietin 3000 units in normal saline, and erythropoietin 6000 units in normal saline every 6 hours respectively. Meanwhile, all patients will receive the usual treatments based on the cause of scleral necrosis.

Eye examinations will be done daily in the first week, every other day in the second week, and then twice a week until the complete recovery of avascular lesions. In each examination, with fluorescein staining, the size of the conjunctival epithelial defect will be determined. Also, the dimensions of the avascular area of the sclera will be determined. Other examinations include measurement of visual acuity and intraocular pressure, and the patient will be evaluated in terms of iris and retinal neovascularization. The photoslit lamp will be done before starting the study and then every week.

Complete healing of the lesion is defined by complete vascularization and epithelization of the ischemia site. After the complete recovery of conjunctival and scleral necrosis, the erythropoietin drop will be stopped and the examinations including blood pressure measurement, CBC, diff and FBS will be repeated.

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, Care Provider)

入排标准

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

入选标准

  • patients with acute conjunctival and scleral avascular lesions resulting from ocular surgery (such as pterygium resection, glaucoma, strabismus, vitreous and retinal surgery), chemical and thermal burns, and collagen-vascular disease.

排除标准

  • a history of ocular surface tumors
  • a history of tumors in any part of the body
  • iris and retinal neovascularization for any reason
  • proliferative diabetic retinopathy
  • and systemic hypertension
  • if the sclera is severely thinned and the risk of perforation of the globe is imminent, the patient is excluded from the study.

研究组 & 干预措施

Prescribe Erythropoieti

Active Comparator

干预措施: Erythropoietin prescription (Drug)

Prescribe placebo

Placebo Comparator

干预措施: Prescription of placebo (Drug)

结局指标

主要结局

The size of the conjunctival epithelial defect

时间窗: 1 week

Caliper

次要结局

  • The rate of angiogenesis at the site of the epithelial defect(1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zahra Rabbani Khah

Head of Ophthalmic Research Center

Shahid Beheshti University of Medical Sciences

研究点 (1)

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