Compare the Clinical Efficacy of 3% Diquafosol and 0.1% Hyaluronic Acid in Patients with Dry Eye After Trans-PRK
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 主要终点
- Non-invasive tear break-up time (NITBUT)
研究概览
简要总结
The prevalence of refractive ametropia is rising year by year. Refractive surgery has become the main approach for adults to correct refractive ametropia, and postoperative complications have aroused extensive attention from clinicians. Dry eye after refractive surgery is one of the postoperative complications, which is an important cause of affecting the postoperative visual quality and satisfaction of patients. It was reported that 3% diquafosol (DQS) and 0.1% hyaluronic acid (HA) can relieve dry eye symptoms. This study aims to compare the efficacy of 3% DQS and 0.1% HA in treating dry eye after Trans-PRK
详细描述
The development of corneal refractive surgery is rapid, but the complications are still inevitable; postoperative dry eye is one of them. Dry eye after refractive surgery will affect not only the patient's postoperative satisfaction but also the patient's postoperative visual quality, resulting in blurred vision, not lasting vision, and other problems. The occurrence of postoperative dry eye is mainly due to using anesthetics during operation; corneal nerve injury and cell apoptosis; changes in corneal curvature; postoperative medication, and so on. The patient's bad living habits may aggravate the degree of postoperative dry eye.
Diquafosol sodium is a P2Y2 receptor agonist. P2Y2 receptors are present on conjunctival and corneal epithelial cells, among others, on the ocular surface. When diquafosol sodium is used, it can activate P2Y2 receptors on these cells. This activation triggers the opening of intracellular signaling pathways that stimulate tear secretion. Normal tear secretion is important for corneal nerve repair because tears contain a variety of nutrients and growth factors. In the state of dry eye, the inflammatory factors on the ocular surface increase, and the stability of the tear film decreases. Diquafosol sodium can help to restore the stability of tear film by promoting tear secretion. A stable tear film reduces corneal nerve stimulation by inflammatory factors on the ocular surface. A large area of corneal nerves is injured during Trans-PRK surgery, and no study has shown that diquafosol sodium has a role in nerve recovery after Trans-PRK Hyaluronic acid (HA) lubricates, relieving dry eyes, astringent eyes, and eye fatigue. It can also flush and dilute inflammatory mediators on the ocular surface, reduce tear osmotic pressure, promote ocular surface epithelial healing, and promote ocular surface fibronectin secretion and deposition.
This study aims to compare the efficacy of 3% diquafosol and 0.1% hyaluronic acid in treating dry eye after Trans-PRK. The observation of changes in corneal nerves and immune-inflammatory cells was added, aiming to observe the repair effect of difossol sodium on corneal nerves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-40 years.
- •The refractive status should be maintained at least for more than 2 years, during which the annual increase in myopia should be controlled within 0.50 D.
- •Pherical equivalent (SE) ≤-6.00D, astigmatic power≤-2.00D.
- •Best corrected vision before surgery≥1.
- •Patients should stop wearing soft contact lenses for at least 2 weeks and hard contact lenses for at least 4 weeks before surgery.
- •Postoperative corneal stromal thickness was preserved (280 μm).
排除标准
- •Suspected of having keratoconus, a definite diagnosis of keratoconus, or another type of corneal dilatation disease.
- •There is active inflammation or symptoms of infection in the eye.
- •The thickness of the cornea does not meet the preset cutting depth requirement: the thickness of the central cornea should be greater than 450 μm, and the thickness of the central corneal stroma remaining under the corneal flap should be maintained above 250 μm after the intended cutting (280 μm recommended).
- •There are serious lesions in the accessory structures of the eye, such as defects or deformations of the eyelids.
- •People with uncontrolled systemic connective tissue diseases and autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis.
研究组 & 干预措施
Study group
dry eye patients after Trans-PRK
干预措施: 3% Diquafosol Sodium Eye Drops (Drug)
Control group
dry eye patients after Trans-PRK
干预措施: 0.1% hyaluronic acid (Drug)
结局指标
主要结局
Non-invasive tear break-up time (NITBUT)
时间窗: day 1, week 1, week 4, week 12 and week 24
The Keratograph 5M (Oculus, Germany) topographer will assess non-invasive tear breakup time.Three sequential readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.
次要结局
- Conjunctivocorneal staining (CS)(day 1, week 1, week 4, week 12 and week 24)
- Tear film lipid layer (TFLL) score(day 1, week 1, week 4, week 12 and week 24)
- Corneal Sensitivity Score(day 1, week 1, week 4, week 12 and week 24)
- Tear meniscus height (TMH)(day 1, week 1, week 4, week 12 and week 24)
- Conjunctival hyperemia (RS score):(day 1, week 1, week 4, week 12 and week 24)
- Meibomian quality(day 1, week 1, week 4, week 12 and week 24)
- Corneal nerves and immune/inflammatory cell change:(1 week, 12 weeks and 24 weeks after surgery.)
- OSDI(day 1, week 1, week 4, week 12 and week 24)
- Meibomian gland expressibility(day 1, week 1, week 4, week 12 and week 24)