Effects of Systemic Isotretinoin Therapy on Choroidal Thickness and Retinal Vascular Parameters in Nodulocystic Acne Patients:A Prospevtive Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
研究概览
简要总结
The dermatologist created a treatment plan for participants diagnosed with acne using medications containing vitamin A. While this medication has many benefits for the skin, it also has various side effects affecting many other systems. One of the most important of these side effects is related to the eyes. Therefore, the dermatologist will refer participants to an eye clinic for eye exams before and at regular intervals after starting this medication. During these exams, the investigators will perform eye measurements, a dry eye test, and an eye CT scan (OCTA). This study will compare patients who are scheduled to start treatment with vitamin A-containing pills for acne treatment with patients who have started treatment and completed their sixth month. This will allow for the early detection of potential side effects associated with this medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being over 18 years of age
- •Having been diagnosed with cystic acne
排除标准
- •History of glaucoma or ocular hypertension
- •Prior ocular surgical interventions
- •Any diagnosed ophthalmic condition,
- •Refractive errors exceeding 1.00 diopter axial length outside the 22 mm to 24 mm range
- •Oongoing dry eye therapy
- •Any systemic/local disorder known to impact retinal or choroidal vascularite or thickness.
结局指标
主要结局
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
时间窗: From enrollment to the end of treatment at 24 weeks
In the participant group receiving treatment for through study completion, any statistically significant change in DVD, SVD, CVD values or Shirmer test scores in OCTA data will be considered a treatment-related side effect.
次要结局
未报告次要终点
研究者
Demet Mutlu
Sponsor-Investigator
Kayseri City Hospital