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 volunteersQualifiers
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
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
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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
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.
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.
Locations
Sponsors and contacts
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