跳至主要内容
临床试验/NCT04733846
NCT04733846已完成不适用

Treatment of Corneal Wounds Emergencies During the COVID-19 Shutdown: Absorbable 10-0 Vicryl Sutures as a Valuable Strategy.

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
change visual acuity (Snellen scale) from baseline and 2, 6, 12 and 18 months after the intervention

研究概览

简要总结

Vicryl (polyglactin) 10-0 resorbable suture is rarely used, little known to ophthalmologists but may offer therapeutic and practical advantages in eligible cases of corneal trauma, particularly during a COVID-19 pandemic.

This has imposed new sanitary restrictions : limited access to the operating room in ophthalmology only for functional emergencies and a drastically reduced capacity for external consultations in favor of teleconsultation. The aim of this study is to evaluate the Vicryl 10-0 (polyglactin 910) resorbable monofilament suture in corneal trauma, rather than classic Nylon 10-0: structural and functional results, and adaptation of postoperative follow-up during a sanitary crisis period.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Corneal penetrating injury and/or lamellar laceration

排除标准

  • Corneal Penetrating injury trauma requiring necessarily ONLY Nylon 10-0
  • Traumatism requiring necessarily a cryopreserved human amniotic membrane (for example)
  • Traumatism eligible for biological glue (long-axis wound < 2 mm)

结局指标

主要结局

change visual acuity (Snellen scale) from baseline and 2, 6, 12 and 18 months after the intervention

时间窗: Months: 0, 2, 6, 12, 18

Collected in the medical record.

change Visual acuity (Parinaud scale) from baseline and 2, 6, 12 and 18 months after the intervention

时间窗: Months: 0, 2, 6, 12, 18

Collected in the medical record.

次要结局

  • Number of postoperative external consultations(Months: 0, 2, 6, 12, 18)
  • Astigmatism (diopter)(Months: 0, 2, 6, 12, 18)
  • Adverse events(Months: 0, 2, 6, 12, 18)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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