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临床试验/NCT07242846
NCT07242846已完成4 期

EFFECT OF INTRAARTICULAR TRIAMCINOLONE HEXACETONIDE AND BETAMETHASONE ON INTRAOCULAR PRESSURE: A PROSPECTIVE RANDOMIZED STUDY

Nigde Omer Halisdemir University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年10月2日最近更新:
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Change in Intraocular Pressure (IOP) From Baseline to 1 Week

研究概览

简要总结

This study is being done to find out whether two commonly used corticosteroid injections for knee osteoarthritis - betamethasone and triamcinolone hexacetonide - have different effects on eye pressure (intraocular pressure). Adults with painful early-stage knee osteoarthritis who have not improved with standard treatments receive one of these injections into the knee joint as part of their usual care. Eye pressure in both eyes is measured before the injection and one week later. By comparing the change in eye pressure between the two steroid groups, the study aims to better understand the risk of steroid-related increases in eye pressure and to help doctors choose safer treatment options, especially for patients who may be at risk for glaucom

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptomatic early-stage knee osteoarthritis Patients aged 18-75 years No prior eye surgery No history of elevated IOP or glaucoma diagnosis Patients not receiving any medical treatment altering IOP

排除标准

  • IOP >21 mm Hg Patients with a previous or current diagnosis of glaucoma Patients aged <18 and >75 years History of or ongoing ocular disease Use of medications (oral CSs, diazoxide, etc.) altering IOP

研究组 & 干预措施

Betamethasone

Active Comparator

Intraarticular betamethasone group

干预措施: Diprospan (Drug)

Triamcinolone Hexacetonide

Active Comparator

Intraarticular triamcinolone hexacetonide

干预措施: artropan (Drug)

结局指标

主要结局

Change in Intraocular Pressure (IOP) From Baseline to 1 Week

时间窗: Baseline (before intra-articular steroid injection) and 1 week after injection

ntraocular pressure (IOP) in both eyes will be measured in mmHg using noncontact tonometry at baseline (before the intra-articular injection) and 1 week after the injection. Change in IOP (ΔIOP) will be calculated for each eye as the value at 1 week minus the baseline value. The primary outcome is the mean change in IOP in each treatment group

次要结局

未报告次要终点

研究者

发起方
Nigde Omer Halisdemir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hilal YAĞAR

Assist. Prof

Nigde Omer Halisdemir University

研究点 (1)

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