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临床试验/NCT05631054
NCT05631054招募中不适用

Establishment and Validation of a Risk Prediction Model for Long-term Low Vision After Vitrectomy in Proliferative Diabetic Retinopathy Patients

Tianjin Medical University Eye Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2022年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
1
主要终点
Best corrected visual acuity at the last follow-up

研究概览

简要总结

Diabetic retinopathy (DR) is the main cause of blindness among working-age adults in the world. Proliferative diabetic retinopathy (PDR) is the severe stage of DR, which is characterized by neovascularization of the retina. Vitreous hemorrhage and traction retinal detachment caused by PDR often require vitrectomy. The purpose of vitrectomy is to remove vitreous hemorrhage, peel off the preretinal proliferative membrane and help restore the retina. With the deepening of people's understanding of diabetes and the development and application of various hypoglycemic drugs, the life expectancy of patients with diabetes continues to prolong. Therefore, the goal of vitrectomy in patients with DR is not only to prevent blindness, but also to maintain good vision for a long time. The purpose of this study is to analyze the risk factors related to the occurrence of long-term low vision postoperatively and establish a risk prediction model, which can help patients adjust their psychological expectations reasonably and promote communication between doctors and patients.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • Voluntary and able to sign an informed consent form
  • Age ≥18 years
  • Documented diagnosis of diabetes mellitus (type I or type II diabetes) defined by the American Diabetes Association or World Health Organization criteria.
  • Unabsorbed vitreous hemorrhage lasted for more than 2 weeks, with or without tractional retinal detachment examen by slit lamp, B-ultrasound and fundus color photography.

排除标准

  • Patients with less than 12 months of follow-up
  • Previous intraocular surgery (eg. corneal transplantation, glaucoma filtering, vitrectomy, except cataract surgery)
  • Complicated with other retinal diseases
  • Underwent surgery (eg. intravitreal injection, cataract surgery) of the study eye within 3 months
  • Lack of medical records.

结局指标

主要结局

Best corrected visual acuity at the last follow-up

时间窗: 1 year

Standard logarithmic visual acuity scale

次要结局

  • The occurrence of re-vitrectomy(1 year)
  • The occurrence of neovascular glaucoma(1 year)
  • The occurrence of vitrectomy for the fellow eye(1 year)

研究者

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

Bojie Hu

Professor

Tianjin Medical University Eye Hospital

研究点 (1)

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