Immediate Effects of Lipid-Based Artificial Tears (Mineral Oil and Hydroxypropyl Guar) and Non-Lipid Artificial Tears (Hydroxypropyl Guar) on Corneal Aberrations in Healthy Individuals
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in Corneal Higher-Order Aberrations (HOAs)
研究概览
简要总结
This study evaluates the immediate effects of two types of artificial tear formulations on corneal aberrations in a healthy population. The interventions include a lipid-based formulation containing mineral oil and hydroxypropyl guar, and a non-lipid formulation containing hydroxypropyl guar alone. Participants will receive a single instillation of each formulation in separate eyes, with measurements of corneal aberrations taken before and 15 minutes after instillation. The study aims to compare the optical changes induced by these formulations and assess their impact on the ocular surface quality.
详细描述
This study explores the immediate effects of two types of artificial tear formulations on corneal aberrations in healthy individuals. The primary aim is to evaluate how a lipid-based formulation containing mineral oil and hydroxypropyl guar and a non-lipid formulation containing hydroxypropyl guar alone influence optical quality shortly after instillation. The results of this research will contribute to a better understanding of how these formulations interact with the ocular surface to enhance or alter corneal optical properties.
The study will involve healthy participants aged 18 to 35 years, with no prior history of ocular surface disease, refractive surgery, or contact lens use. All participants will undergo a baseline assessment of corneal aberrations before any intervention. Each individual will then receive a single drop of the lipid-based formulation in one eye and the non-lipid formulation in the other eye. This approach allows for direct comparison between the two interventions within the same participant. Measurements of corneal aberrations will be taken 15 minutes after instillation to capture the immediate effects of each formulation on optical quality.
The study is designed as a randomized, participant-masked clinical trial to ensure unbiased results. By measuring higher-order aberrations (HOAs) with wavefront aberrometry, the research will assess how these artificial tears affect the ocular surface's optical properties. This will provide valuable insights into their potential to stabilize the tear film and enhance visual performance. The trial follows ethical guidelines and has been approved by the appropriate Institutional Review Board.
This research is important for advancing knowledge about artificial tear formulations and their role in managing ocular surface conditions. Although both formulations are commonly used in clinical practice, their specific effects on corneal aberrations immediately after application have not been thoroughly studied in a healthy population. The findings from this study will help inform healthcare providers and patients about the optical benefits and limitations of these widely used artificial tear formulations.
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)
盲法说明
Participants, investigators, and outcomes assessors will not know which formulation is being administered. Identical containers and consistent procedures will ensure masking.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals aged 18 to 35 years. No prior history of ocular surface disease, refractive surgery, or contact lens wear.
- •Corrected visual acuity of 20/20 or better. Ability to provide informed consent. Willingness to comply with study procedures, including instillation of artificial tears and follow-up measurements.
排除标准
- •History of any ocular surgery or trauma within the past six months. Use of any systemic or topical medications that may affect ocular surface stability or tear film.
- •Any active or chronic ocular infection, inflammation, or other pathology. Known hypersensitivity or allergy to any components of the artificial tears. Pregnancy or breastfeeding. Participation in another clinical trial within the last 30 days.
研究组 & 干预措施
Lipid-Based Artificial Tear Formulation
Participants in this arm will receive a single drop of a lipid-based artificial tear formulation containing mineral oil and hydroxypropyl guar in each eye. The intervention is designed to enhance the lipid layer of the tear film and will be evaluated for its immediate effects on corneal aberrations 15 minutes post-instillation.
干预措施: Lipid-Based Artificial Tear (Drug)
Non-Lipid Artificial Tear Formulation
Participants in this arm will receive a single drop of a non-lipid artificial tear formulation containing hydroxypropyl guar in each eye. The intervention aims to improve aqueous layer stability and will be assessed for its immediate effects on corneal aberrations 15 minutes post-instillation.
干预措施: Non-Lipid Artificial Tear (Drug)
结局指标
主要结局
Changes in Corneal Higher-Order Aberrations (HOAs)
时间窗: Baseline to 15 minutes post-instillation
The primary outcome is the change in corneal higher-order aberrations (measured as RMS values) using wavefront aberrometry. Measurements will assess the optical impact of the lipid-based and non-lipid artificial tear formulations on the ocular surface.
次要结局
- Stabilization of Tear Film(Baseline to 15 minutes post-instillation)
研究者
José-María Sánchez-González
Optometry Doctor, PhD
University of Seville