Assessing Patient Comfort, Anxiety, and Satisfaction During Cycloplegic Refraction: Comparing Conventional Drops With Rapid-Onset Cycloplegics
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
This study aims to compare the efficacy of conventional cycloplegic agents, such as cyclopentolate, with rapid-onset cycloplegics, like a combination of tropicamide and phenylephrine, in reducing patient anxiety and discomfort during cycloplegic refraction. Cycloplegic refraction is an essential procedure for diagnosing refractive errors, particularly in children, by temporarily paralyzing the ciliary muscle to inhibit accommodation. While cyclopentolate has a relatively quick onset, tropicamide is preferred due to its faster onset and shorter duration. Despite its advantages, concerns about patient discomfort and anxiety during the procedure remain, especially in pediatric populations.
详细描述
The study will involve participants aged 3-16 years, with no significant refractive error or ocular pathologies. Patients will be randomly assigned to receive either cyclopentolate or tropicamide with phenylephrine. The primary outcomes include patient comfort, anxiety levels, satisfaction, and procedure time. Discomfort and anxiety will be measured using questionnaires such as the Visual Analog Scale for Comfort and the State-Trait Anxiety Inventory. The study will help determine if rapid-onset cycloplegic provide a better patient experience by reducing discomfort and anxiety. By evaluating these factors, the research seeks to improve clinical practices in optometry and ophthalmology, particularly in pediatric eye examinations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 10-20years.
- •Both Male and Female
- •Healthy participants with no abnormalities detected in anterior segment structures or fundus examination using slit-lamp biomicroscopy and a 90-diopter lens.
- •No significant refractive error (within the range of ±1 diopter in spherical equivalent).
排除标准
- •History of severe allergic reactions or adverse effects to cycloplegic agents
- •Severe anxiety, panic disorders, or other psychological conditions that may interfere with reporting the experience accurately.
- •Uncontrolled systemic diseases (e.g., uncontrolled diabetes or cardiovascular conditions) that may impact the response to cycloplegic agents.
- •Recent ocular surgery (e.g., LASIK, cataract surgery) or eye trauma affecting refraction accuracy or comfort.
- •Presence or history of any intraocular diseases, including glaucoma, uveitis, and retinal disorders.
- •Systemic disorders such as hypertension, cardiovascular disease, or respiratory disease.
研究组 & 干预措施
Rapid-Onset Cycloplegic Drops
干预措施: Rapid-Onset Cycloplegic Drops (Combination Product)
Conventional Cycloplegic Drops
干预措施: Conventional Cycloplegic Drops (Diagnostic Test)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: 12 Months
The Visual Analogue Scale (VAS) score is a pain measurement tool where patients mark a point on a 10 cm line representing their pain intensity, with the distance from "no pain" measured in millimeters (0-100), indicating pain intensity
State-Trait Anxiety Inventory (STAI)
时间窗: 12 Months
The State-Trait Anxiety Inventory (STAI) is a 40-item self-report questionnaire measuring anxiety, divided into 20 items for state anxiety (how one feels now) and 20 for trait anxiety (how one generally feels). Each item is scored on a 4-point Likert scale, with higher scores indicating greater anxiety
次要结局
未报告次要终点
研究者
Muhammad Naveed Babur
Principal Investigator
Superior University