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

February 21, 2025 updated by: He Eye Hospital
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Study group
dry eye patients after Trans-PRK
Drug: 3% Diquafosol Sodium Eye Drops
3% Diquafosol Sodium Eye Drops were instilled into the inferior conjunctival vault of both eyes
Other: Control group
dry eye patients after Trans-PRK
Drug: 0.1% hyaluronic acid
0.1% sodium hyaluronate eye drops were instillation into the inferior conjunctival vault of both eyes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 1, week 1, week 4, week 12 and week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 1, week 1, week 4, week 12 and week 24
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
day 1, week 1, week 4, week 12 and week 24
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.
day 1, week 1, week 4, week 12 and week 24
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.
day 1, week 1, week 4, week 12 and week 24
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).
day 1, week 1, week 4, week 12 and week 24
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).
day 1, week 1, week 4, week 12 and week 24
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.
1 week, 12 weeks and 24 weeks after surgery.
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.
day 1, week 1, week 4, week 12 and week 24
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.
day 1, week 1, week 4, week 12 and week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

He Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 28, 2025

Primary Completion (Estimated)

May 28, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRK2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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