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临床试验/NCT06638424
NCT06638424招募中不适用

Study of the Impact of Cataract Surgery on the Corneal Epithelium and Ocular Surface of Diabetic Patients

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
To assess whether cataract surgery induces an increased risk of corneal epithelial alterations in diabetic patients

研究概览

简要总结

Diabetes is one of the most common fatal metabolic diseases in the world. Diabetes-induced ocular surface alterations are poorly understood. Indeed, it was once thought that the cornea, avascular, was immune to the effects of diabetes. A growing number of publications now demonstrate the opposite. These alterations affect up to 70% of diabetic patients at some point in the progression of their diabetes.

Another common complication of diabetes is the early development of a cataract, requiring surgery. Diabetic patients are therefore more likely to require surgery at an early age than the general population.

Diabetes and cataract surgery both induce corneal changes. Cataract surgery in diabetic patients is therefore at greater risk of corneal complications. Diabetes induces dysfunction of the main lacrimal gland, corneal neuropathy, meibomian dysfunction and a decrease in conjunctival mucus cells. Diabetic patients are therefore particularly at risk of exacerbation or appearance of alterations of the corneal epithelium and the ocular surface in postoperative cataract surgery.

Therefore, it seems necessary to evaluate the impact of cataract surgery on the ocular surface and corneal epithelium of diabetic patients, in order to improve their management.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Adult patient (≥18 years);
  • Patient operated on for cataract at HUS between January 2022 and January 2024;
  • Patient who did not express his opposition to the reuse of his data for scientific research purposes;
  • Patient who benefited from the measurement of the above-mentioned judgment criteria during his pre- and post-operative consultations.

排除标准

  • Presence in the medical file of the subject's opposition to the reuse of his data for scientific research purposes.
  • Prolonged use of stored eye drops;
  • Documented etiology of chronic alteration of the ocular surface (shingles, herpes, Gougerot-Sjogren syndrome, graft-versus-host disease);
  • Minor patient or under guardianship or curatorship.

结局指标

主要结局

To assess whether cataract surgery induces an increased risk of corneal epithelial alterations in diabetic patients

时间窗: One month before and one month after surgery

The six Oxford scheme grades (0-5), which denote the severity of dry eye, are used to record the results: * Stage 0 or 1: Mild * Stage 2 or 3: Moderate * Stage 4 or 5: Severe

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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