The Effects of Androgen Replacement Therapy on Tear Osmolarity and Ocular Surface Parameters in Androgen Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Tear Osmolarity in mOsm/L
研究概览
简要总结
Objective: To evaluate tear osmolarity and ocular surface findings in men with androgen deficiency (AD) and assess changes after androgen replacement therapy (ART).
Design: A prospective interventional study. Participants and Methods Right eyes of 77 male participants were evaluated in this study. Serum total testosterone level were measured, and participants were categorized as AD group (testicular hypofunction, n=37, testosterone level <231 ng/dL) and control group (healthy controls, n=40, testosterone level >346 ng/dL). The parameters including Aging Male Symptoms Scale(AMS), OSDI scores, Meibomian Gland Dysfunction- Grading System(MGD-GS) scores, corneal staining, tear break-up time(TBUT), Schirmer I/II tests, tear osmolarity, the depth (TMD), the height (TMH) and the area (TMA) of inferior tear meniscus were investigated. AD group received intramuscular testosterone every two weeks.
Main Outcome Measures: The changes in the ocular surface parameters were investigated during the ART while comparing the values of these parameters between the AD and control groups at baseline, 6th and 18th weeks of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Androgen deficiency
排除标准
- •having any ocular disease, history of surgery, drop use
研究组 & 干预措施
testosterone
干预措施: androgen replacement therapy (Drug)
结局指标
主要结局
Tear Osmolarity in mOsm/L
时间窗: 5 months
Tear osmolarity was measured by TearLab device in patients. The changes in the tear osmolarity were investigated during the ART while comparing the values of these parameters between the AD and control groups at baseline, 6th and 18th weeks of the treatment.
Schirmer Test in mm
时间窗: 5 months
Schirmer Test is applied by Schirmer tear paper after anesthesic drop administration into the eye.
Tear break-up time (TBUT) in sec
时间窗: 5 months
TBUT is measured by ophthalmologist after application of fluorecein dye.
MGD-GS score in number
时间窗: 5 months
MGD-GS score was performed by ophthalmolgist using biomicroscopy
Questionary Scoring in number
时间窗: 5 months
AMS and OSDI scoring charts were completed by the participants.
Optical Coherence Tomography findings: TMH, TMA, and TMD in microns
时间窗: 5 months
Tear meniscus height (TMH), area (TMA), and depth (TMD) were measured by Optical coherence tomography in each participants.
次要结局
未报告次要终点