Compare the Clinical Efficacy of 3% Diquafosol and 0.1% Hyaluronic Acid in Patients With Dry Eye After LASIK

ConditionDry Eye
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 LASIK

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Study groupExperimental treatment 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
Baseline, week 4, week 12 and week 24

Secondary 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
Baseline, week 4, week 12 and week 24
2

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
Baseline, week 4, week 12 and week 24
3

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
Baseline, week 4, week 12 and week 24
4

Tear meniscus height (TMH)

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

Time frame
Baseline, week 4, week 12 and week 24

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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