跳至主要内容
临床试验/NCT06734663
NCT06734663尚未招募不适用

Clinical Outcomes of Sutured Versus Sutureless Conjunctival Autograft in Primary Pterygium Excision

Assiut University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
2
主要终点
to evaluate the rate of conjuctival graft displacement in pterygium excision and graft placement without sutures

研究概览

简要总结

The goal of this study is to find out if a certain technique in pterygium excision surgery ,using no sutures, is better than the technique mostly used ,which uses sutures.

Investigators aim to find out whether the no sutures technique provides better efficiency and patient satisfaction than the traditional approach. They predict that if this study provides evidence of the advantages of this technique over the one used, surgeons would be encouraged to use it instead. Because not only would the patient benefit, the surgeon also may save operative time and effort used in the technique which uses sutures.

详细描述

This study is a comparative interventional study, in which patients are assigned into two groups comparable in age, gender, and general condition. The first group consists of patients with primary pterygium who will undergo surgery in a traditional approach in which the pterygium is surgically removed and after which a conjuctival graft is placed on the exposed sclera and sutured to the surrounding conjuctiva; in comparison, patients of the second group undergo pterygium excision in a similar matter initially.But the conjuctival graft is placed on the exposed sclera without suturing it to the nearby conjuctiva; instead, the graft remains in place using the patient's autologous blood. Fresh blood is left under the graft, while the surgeon merely compresses the graft for a few minutes. The aim of this study is to reach a conclusion as to which technique is more beneficial, to the patient and surgeon.

Patients included in this study must have primary pterygium, no known hematological condition, and full consent to the study. Surgery time is recorded to compare the effect of avoiding sutures on the surgeon's speed. After that, Patients are followed up in documented certain intervals post-operative, to assess graft displacement, signs of inflammation, signs of bleeding under graft, and patients' overall discomfort and satisfaction.

Finally, the two groups are compared with all factors taken into consideration. The ultimate target is to document evidence of the efficiency of the sutureless technique and endorse its application by Ophthalmologists elsewhere.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged between 18-60 years old.
  • •Patients diagnosed with primary Pterygium (Grades 1-4)

排除标准

  • •Patients unable to offer viable consent
  • •Patients with other significant ocular surface diseases, bleeding disorders, or systemic conditions affecting wound healing.)
  • •Recurrent pterygium
  • •Combined ocular surgery

研究组 & 干预措施

pterygium excision using sutured technique

Placebo Comparator

This represents the main used technique in pterygium surgery that we will compare the less familiar sutureless technique to. pterygium is surgically removed and conjuctival graft is placed using sutures

干预措施: Clinical outcomes of sutured versus sutureless conjunctival autograft in primary pterygium excision (Procedure)

pterygium excision using sutured technique

Placebo Comparator

This represents the main used technique in pterygium surgery that we will compare the less familiar sutureless technique to. pterygium is surgically removed and conjuctival graft is placed using sutures

干预措施: pterygium excision and conjuctival graft suturing (Procedure)

sutureless technique

Active Comparator

this represents the experimented technique in which pterygium excision is done and the graft is placed sutureless.

干预措施: Clinical outcomes of sutured versus sutureless conjunctival autograft in primary pterygium excision (Procedure)

sutureless technique

Active Comparator

this represents the experimented technique in which pterygium excision is done and the graft is placed sutureless.

干预措施: pterygium excision and conjuctival graft placement by autologous blood (Procedure)

结局指标

主要结局

to evaluate the rate of conjuctival graft displacement in pterygium excision and graft placement without sutures

时间窗: 3 months

the most valuable aim in this comparative study is to document if the graft placed sutureless will remain in place.So, in each follow-up, graft is assessed in regards to placement.

次要结局

未报告次要终点

研究者

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

Amal Sherif Sayed Abdelrehim

Resident at Ophthalmology department, Faculty of medicine, Assiut University

Assiut University

研究点 (2)

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