Comparison of Tear Film Stability and Ocular Surface Health Between Low TDS and High TDS Drinking Water Consumers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
研究概览
简要总结
Dry eye disease is a multifactorial disorder of the ocular surface characterized by tear film instability, ocular discomfort, and potential damage to the ocular surface. Environmental and systemic factors may influence the stability and quality of the tear film. Total Dissolved Solids (TDS) in drinking water represent the concentration of dissolved minerals and salts, which may affect systemic electrolyte balance and potentially influence ocular surface physiology. This comparative cross-sectional observational study aims to evaluate the association between drinking water TDS levels and tear film stability as well as ocular surface health. Participants aged 25 to 50 years who have been consuming the same household drinking water source for at least six months will be included in the study. Household drinking water samples will be collected and analyzed for TDS levels, and participants will be categorized into low-TDS (less than 300 ppm) and high-TDS (greater than 500 ppm) groups. Ocular surface assessment will include Tear Break-Up Time (TBUT), Schirmer’s I test, corneal and conjunctival fluorescein staining, and the Ocular Surface Disease Index (OSDI) questionnaire. In addition, serum electrolyte levels will be measured to explore possible correlations between systemic electrolyte status and ocular surface parameters. The study aims to identify whether differences in drinking water mineral content are associated with variations in tear film stability and ocular surface health.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 25 to 50 years Individuals consuming the same primary household drinking water source for at least 6 months Participants willing to provide a household drinking water sample for Total Dissolved Solids (TDS) measurement Individuals whose drinking water TDS falls into the study categories: Low-TDS (less than 300 ppm) or High-TDS (greater than 500 ppm) Participants able to undergo ocular surface evaluation including Tear Break-Up Time (TBUT), Schirmer’s I test, and corneal and conjunctival staining and complete the OSDI questionnaire Individuals with no active ocular infection or ocular allergy at the time of enrolment Participants willing and able to provide written informed consent and comply with study procedures.
排除标准
- •History of ocular surgery or ocular trauma within the past 6 months Presence of active ocular infection, inflammation, or significant ocular allergy at the time of screening (e.g., conjunctivitis, keratitis, uveitis) Presence of ocular surface diseases other than dry eye that may affect tear film assessment (e.g., pterygium involving the cornea, severe blepharitis, meibomian gland dysfunction) Current use of topical ocular medications (including lubricants, steroids, antibiotics, or anti-glaucoma medications) within the past 4 weeks Contact lens users currently or within the past 1 month History of systemic autoimmune diseases affecting tear production such as Sjögren’s syndrome, rheumatoid arthritis, or other autoimmune disorders Individuals taking systemic medications known to affect tear secretion (e.g., antihistamines, antidepressants, anticholinergics, isotretinoin, or long-term diuretics) Uncontrolled systemic diseases that may influence tear film physiology (e.g., uncontrolled diabetes mellitus) History of radiotherapy or chemotherapy Pregnant or lactating women Individuals with inconsistent drinking water sources or frequent change of drinking water source within the past 6 to 12 months Participants unwilling or unable to provide a drinking water sample or written informed consent, or unable to cooperate with ocular surface tests (TBUT, Schirmer’s I, OSDI).
研究者
Ratan Lal Rastogi
Galgotias University