Prospective, Randomized Cross-over Within-subject Study on the Effects of Dehydration and Hyperhydration on Macular Thickness, Corneal Morphology, and Ocular Biometric Parameters Measured by OCT, Pentacam and Optical Biometer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Change in macular thickness between dehydration and hyperhydration states
研究概览
简要总结
This study will examine how hydration status (drinking a large amount of water or avoiding water for a short period of time) affects the eye. Healthy adult volunteers will participate in two sessions: one after mild dehydration (no water for 12 hours) and one after drinking 2 liters of water within 4 hours. At each session, detailed eye measurements will be taken, including scans of the retina and optic nerve using optical coherence tomography (OCT), corneal imaging with Pentacam, and eye length measurements with an optical biometer. The results from the two conditions will be compared within the same participants.
The main goal is to determine whether hydration influences the thickness of the retina (macula). Secondary goals include assessing changes in the optic nerve, cornea, and other biometric eye parameters. The study involves only non-invasive tests and minimal risk. Findings may help improve understanding of how hydration affects the eye and may be important for clinical practice, such as planning cataract or refractive surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged 18 to 65 years
- •Normal ophthalmological findings
- •Best corrected visual acuity (BCVA) ≥ 1.0 (decimal)
- •Willingness to participate and provide written informed consent
排除标准
- •Known ocular diseases (e.g., glaucoma, keratoconus, retinal pathology)
- •History of ocular surgery
- •Systemic diseases affecting hydration status (e.g., diabetes mellitus, kidney disease)
- •Any condition that, in the investigator's opinion, could interfere with study participation or data quality
- •Refusal to participate
结局指标
主要结局
Change in macular thickness between dehydration and hyperhydration states
时间窗: Within 1 week (cross-over design with ≥7-day washout period)
Macular thickness (central subfield, parafoveal, and perifoveal regions) will be measured using Zeiss Cirrus HD-OCT. Each participant will undergo measurements in both hydration states, and paired comparisons will be performed.
次要结局
未报告次要终点
研究者
Ante Kreso
Principal Investigator
University Hospital of Split
