Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06852105

Compare the Clinical Efficacy of 3% Diquafosol and 0.1% Hyaluronic Acid in Patients with Dry Eye After Trans-PRK

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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≥1.0.
  • 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).

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.
  • 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).
  • Dry eye.
  • 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.

Treatment and study plan

3% Diquafosol Sodium Eye Drops

Drug

3% Diquafosol Sodium Eye Drops were instilled into the inferior conjunctival vault of both eyes

0.1% hyaluronic acid

Drug

0.1% sodium hyaluronate eye drops were instillation into the inferior conjunctival vault of both eyes

Primary outcomes

  1. Non-invasive tear break-up time (NITBUT)

    Time frame: 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.

Secondary outcomes

  1. Conjunctivocorneal staining (CS)

    Time frame: day 1, week 1, 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

  2. Tear film lipid layer (TFLL) score

    Time frame: day 1, week 1, 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

  3. Corneal Sensitivity Score

    Time frame: day 1, week 1, 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.

  4. Tear meniscus height (TMH)

    Time frame: day 1, week 1, week 4, week 12 and week 24

    Ear meniscus height using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively, and the median value will be recorded.

  5. Conjunctival hyperemia (RS score):

    Time frame: day 1, week 1, 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).

  6. Meibomian quality

    Time frame: day 1, week 1, 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).

  7. Corneal nerves and immune/inflammatory cell change:

    Time frame: 1 week, 12 weeks and 24 weeks after surgery.

    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.

  8. OSDI

    Time frame: day 1, week 1, 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 aspects of eye discomfort, including eye pain or discomfort, vision-related dysfunction, 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.

  9. Meibomian gland expressibility

    Time frame: day 1, week 1, 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 glands expressible; 1, 3-4 glands expressible; 2, 1-2 glands expressible; and 3, no glands expressible.

Study contacts

Contact information is provided by the study sponsor or research team.

Guanghao Qin Principal Investigator

CONTACT

[email protected]

+86-1884266442

Sponsors and collaborators

Lead sponsor

He Eye Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.