Compare the Clinical Efficacy of 3% Diquafosol and 0.1% Hyaluronic Acid in Patients With Dry Eye After LASIK
- Conditions
- Dry Eye
- Interventions
- Drug: 0.1% hyaluronic acid
- Registration Number
- NCT07097922
- Lead Sponsor
- He Eye Hospital
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 140
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study group 3% Diquafosol Sodium Eye Drops dry eye patients after LASIK Control group 0.1% hyaluronic acid dry eye patients after LASIK
- Primary Outcome Measures
Name Time Method Non-invasive tear break-up time (NITBUT) 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 Outcome Measures
Name Time Method Conjunctivocorneal staining (CS) Baseline, week 4, week 12 and week 24 Fluorescein and lissamine staining of the ocular surface will be divided into three zones comprising nasal conjunctival, corneal, and temporal conjunctival areas. The staining score ranged from 0 to 3 for each zone, yielding a total score of 0-9 for the ocular surface
Tear film lipid layer (TFLL) score Baseline, week 4, week 12 and week 24 Tear film lipid layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan). The results will be graded as follows: grade 1, somewhat gray color, uniform distribution; grade 2, somewhat gray color, nonuniform distribution; grade 3, a few colors, nonuniform distribution; grade 4, many colors, nonuniform distribution; grade 5, corneal surface partially exposed
Corneal Sensitivity Score Baseline, week 4, week 12 and week 24 Corneal sensitivity score measured with a Cochet-Bonnet esthesiometer (in mm filament length); the measurements will be done 3 times at every assessment session, and the median value will be recorded.
Tear meniscus height (TMH) Baseline, week 4, week 12 and week 24 Tear meniscus height using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively, and the median value will be recorded.
Meibomian gland expressibility Baseline, week 4, week 12 and week 24 Meibomian gland expression: five meibomian glands in the middle part were evaluated on a scale of 0-3: 0, all glandsexpressible; 1, 3-4 glands expressible; 2, 1-2 glands expressible; and 3, no glands expressible
Corneal nerves and immune/inflammatory cell change Baseline, week 4, week 12 and week 24 HRT III RCM (Heidelberg Engineering GmbH, Germany) will be used to record corneal nerves and immune/ inflammatory cell change. It can accurately scan the cornea from the upper cortex to the inner cortex and other different depth levels and accurately judge the specific level and scope of the lesion. Three representative images of the subbasal nerve plexus and epithelial DCs will be selected for analysis for each eye, considering criteria such as a whole image in the same layer, best focus, and good contrast.
Conjunctival hyperemia (RS score) Baseline, week 4, week 12 and week 24 Conjunctival hyperemia (RS score) will be assessed by a keratograph image (Oculus, Germany) of 1156 × 873 pixels, with a redness score (RS) ranging from 0.0 (normal) to 4.0 (severe).
Meibomian quality Baseline, week 4, week 12 and week 24 Meibomian quality will be assessed under a slit-lamp; eight meibomian glands in the middle parts of the eyelid will be assessed using a scale of 0 to 3 for each gland (0 represented clear meibum; 1 represented cloudy meibum; 2 represented cloudy and granular meibum; and 3 represented thick, toothpaste-like consistency meibum).
OSDI Baseline, week 4, week 12 and week 24 The Ocular Surface Disease Index (OSDI) is a tool used to assess the degree to which ocular surface disease affects a patient's visual function and related symptoms. It is a subjective, patient-self-reported questionnaire.The questionnaire mainly covers three functions, and eye irritation symptoms. There are usually 12 questions, and the answer options for each question usually include "none," "mild," "moderate," and "severe," and the corresponding scores are 0, 1, 2, and 3. A range of 0-12 is classified as normal or mild symptoms. A range of 13-22 is classified as moderate symptoms. 23-36 is classified as severe symptoms.