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临床试验/NCT07244276
NCT07244276招募中不适用

Comparison of Compression Continuous Suture Versus Conventional Suture for Autologous Conjunctival Implant Fixation in Primary Pterygium Surgery: a Randomized Controlled Trial

Tianjin Eye Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月2日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Duration of surgery

研究概览

简要总结

To compare the advantages and disadvantages of continuous suture with suture and conventional Suture in primary pterygium surgery for autologous conjunctival graft fixation

详细描述

Pterygium is an abnormal fibrovascular tissue hyperplasia disease that occurs in the conjunctiva. The pterygium tissue can break through the limbus of the corneosclera and grow into the cornea, causing a foreign body sensation in the eyes, astigmatism, decreased vision, and even restricted eye movement. The purpose of surgical treatment for pterygium is not only to remove the diseased tissue, but more importantly, to reduce the recurrence of pterygium after surgery. Pterygium excision combined with simple autologous conjunctival transplantation is currently the most commonly used method for treating pterygium. The recurrence rate after autologous conjunctival epithelial tissue transplantation can be reduced to 5% to 30%.

As heterogenic substances, sutures can irritate the ocular surface, aggravate postoperative inflammatory reactions and conjunctival edema or hemorrhage, delay the repair of corneal wound epithelium, lead to abnormal ocular surface function, intensify postoperative discomfort, and induce hypertrophic granuloma or cysts, etc. Moreover, these adverse reactions can also induce the recurrence of pterygium (0-26%). In addition, the longer the time interval between suture removal, The greater the difficulty of removal, the more likely some of the knots may be completely buried under the conjunctiva. Therefore, in order to alleviate the adverse reactions caused by sutures and further simplify the operation of pterygium excision surgery, many attempts have been made at home and abroad to improve and innovate the method of graft fixation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Diagnosis of primary pterygium according to diagnostic criteria;
  • The pterygium head invades the cornea by 2-5mm;
  • The patient agrees to the surgical treatment and signs the surgical consent form.

排除标准

  • History of previous eye surgery;
  • Have active ocular inflammatory lesions;
  • recurrent and pseudopterygium;
  • The patient refuses surgery or is unable to have regular follow-ups

结局指标

主要结局

Duration of surgery

时间窗: Intraoperative

The date on which the surgery was performed

Implant stability

时间窗: Postoperative follow-up was performed 1 day and 1 week after surgery

Whether the conjunctival graft is loose or detached

Postoperative discomfort

时间窗: Postoperative follow-up was performed 1 day and 1 week after surgery

The degree of discomfort after surgery was evaluated using the VAS Pain score Scale

Stitch removal time

时间窗: Postoperative follow-up was performed 1 week after surgery

The date when the stitches were removed

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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