Compare the Clinical Efficacy of 3% Diquafosol and 0.1% Hyaluronic Acid in Patients With Dry Eye After LASIK
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 140
- Primary Endpoint
- Non-invasive tear break-up time (NITBUT)
Study Overview
Brief Summary
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 LASIK
Detailed Description
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 LASIK surgery, and no study has shown that diquafosol sodium has a role in nerve recovery after LASIK 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 LASIK. The observation of changes in corneal nerves and immune-inflammatory cells was added, aiming to observe the repair effect of diquafosol sodium on corneal nerves
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •History of LASIK surgery for more than six months
- •Confirmed dry eye: patients complained of one of the subjective symptoms of ocular dryness, foreign body sensation, burning sensation, fatigue, discomfort, redness of the eyes, and fluctuating visual acuity; as well as (a) OSDI questionnaire score of ≥13 and (b) non-invasive tear break-up time (NITBUT) of <10 s or (c) ocular surface staining assessed in >5 corneal patches/greater than 9 conjunctival patches
- •Participants were able to co-operate with the use of eye drops as required, complete the examination, and return to the hospital within the specified time for follow-up examinations to complete the follow-up visit.
Exclusion Criteria
- •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
- •There are serious lesions in the accessory structures of the eye, such as defects or deformations of the eyelids
- •Patients with Connective tissue diseases and Autoimmune disorders (e.g., SLE, RA)
Arms & Interventions
Study group
dry eye patients after LASIK
Intervention: 3% Diquafosol Sodium Eye Drops (Drug)
Control group
dry eye patients after LASIK
Intervention: 0.1% hyaluronic acid (Drug)
Outcomes
Primary Outcomes
Non-invasive tear break-up time (NITBUT)
Time Frame: Baseline, 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
Secondary Outcomes
- Conjunctivocorneal staining (CS)(Baseline, week 4, week 12 and week 24)
- Tear film lipid layer (TFLL) score(Baseline, week 4, week 12 and week 24)
- Corneal Sensitivity Score(Baseline, week 4, week 12 and week 24)
- Tear meniscus height (TMH)(Baseline, week 4, week 12 and week 24)
- Meibomian gland expressibility(Baseline, week 4, week 12 and week 24)
- Corneal nerves and immune/inflammatory cell change(Baseline, week 4, week 12 and week 24)
- Conjunctival hyperemia (RS score)(Baseline, week 4, week 12 and week 24)
- Meibomian quality(Baseline, week 4, week 12 and week 24)
- OSDI(Baseline, week 4, week 12 and week 24)