Randomized Controlled Trial of the Effects of Sodium Hyaluronate on Wavefront Aberrations in Dry Eye Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Ocular aberrations
研究概览
简要总结
Eyes with abnormal tear film function have been found to show larger optical aberrations than normal eyes which may be attributed to the unstable and irregular tear film, uneven ocular surface, and increased scatter due to the exposure of the rough surface of corneal epithelium after tear break-up.
These hypotheses have been supported by the findings that instillation of artificial tears (sodium hyaluronate preparation) in dry eye patients reduces both corneal and ocular aberrations, improving the optical quality of the retinal image.
However, the previous studies only evaluated the short-term effects of a single administration of an artificial tear but did not determine the duration of action or inflection point at which the ocular aberrations increase back to baseline. Also, there has clearly been no such clinical trial that has been a well randomized controlled study to date.
This report is the first randomized controlled trial that investigated the long-term effects of a single dose of sodium hyaluronate-based artificial tears on wavefront aberrations in patients with dry eye.
详细描述
Parameters used to determine treatment outcomes included ocular aberrations and severity of dry eye symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18 years or over.
- •Documented history of bilateral dry eye for at least 3 months.
- •Schirmer's I test (without anesthesia) less than 10 mm wetting/5 minutes for each eye.
- •Tear film break-up time (TBUT) less than 10 seconds for each eye.
- •Good compliance with the study regimen and availability for the duration of the entire study period.
排除标准
- •Pregnant or lactating women.
- •Contact lens wear.
- •Non-mydriatic pupil size less than 5.0 mm.
- •Other ocular surface pathologies or coexisting ocular diseases.
- •Ocular surgery or trauma within the past 4 months.
- •Use of concomitant eye drops or eye ointments within the past 2 weeks.
- •Abnormality of the nasolacrimal drainage apparatus.
- •Permanent or temporary occlusion of lacrimal puncta in any eye.
- •Known hypersensitivity to hyaluronic acid or any component used in the study.
- •Taking the following systemic medications within the previous 2 months: tricyclic antidepressive agents, anti-histaminic agents, phenothiazines, cholinergic agents, antimuscarinic agents, NSAIDs, beta-blockers, immunomodulators, anti-acneic agents, diuretics, corticosteroids and tetracyclines.
- •Very severe dry eye causing inaccurate aberrometry measurements.
研究组 & 干预措施
Artificial tear
One drop of preservative-free, hypotonic 0.18% sodium hyaluronate in one eye
干预措施: 0.18% sodium hyaluronate (Drug)
Control
one drop of sterile 0.9% sodium chloride solution in the other eye
干预措施: 0.9% sodium chloride solution (Drug)
结局指标
主要结局
Ocular aberrations
时间窗: 120 minutes
A Zywave® II aberrometer which is a wavefront-sensing device based on the Hartmann-Shack principle was used to analyze monochromatic wavefront aberrations of the whole eye.
次要结局
- Adverse reactions and complications(120 minutes)
- Severity of dry eye symptoms(120 minutes)