Compare the Clinical Efficacy of 3% Diquafosol and 0.1% Hyaluronic Acid in Patients with Dry Eye After Trans-PRK
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorHe Eye Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
3% Diquafosol Sodium Eye Drops
Drug3% Diquafosol Sodium Eye Drops were instilled into the inferior conjunctival vault of both eyes
0.1% hyaluronic acid
Drug0.1% sodium hyaluronate eye drops were instillation into the inferior conjunctival vault of both eyes
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Study groupOther 1 intervention
Group B: Control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Non-invasive tear break-up time (NITBUT)
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.
Time frame
day 1, week 1, week 4, week 12 and week 24Secondary outcomes
1
Conjunctivocorneal staining (CS)
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
Time frame
day 1, week 1, week 4, week 12 and week 242
Tear film lipid layer (TFLL) score
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
Time frame
day 1, week 1, week 4, week 12 and week 243
Corneal Sensitivity Score
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.
Time frame
day 1, week 1, week 4, week 12 and week 244
Tear meniscus height (TMH)
Ear meniscus height using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively, and the median value will be recorded.
Time frame
day 1, week 1, week 4, week 12 and week 24Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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