Dry Eye Clinical Trial
Official title:
Randomized Controlled Trial of the Effects of Sodium Hyaluronate on Wavefront Aberrations in Dry Eye Patients
Eyes with abnormal tear film function have been found to show larger optical aberrations
than normal eyes which may be attributed to the unstable and irregular tear film, uneven
ocular surface, and increased scatter due to the exposure of the rough surface of corneal
epithelium after tear break-up.
These hypotheses have been supported by the findings that instillation of artificial tears
(sodium hyaluronate preparation) in dry eye patients reduces both corneal and ocular
aberrations, improving the optical quality of the retinal image.
However, the previous studies only evaluated the short-term effects of a single
administration of an artificial tear but did not determine the duration of action or
inflection point at which the ocular aberrations increase back to baseline. Also, there has
clearly been no such clinical trial that has been a well randomized controlled study to
date.
This report is the first randomized controlled trial that investigated the long-term effects
of a single dose of sodium hyaluronate-based artificial tears on wavefront aberrations in
patients with dry eye.
Parameters used to determine treatment outcomes included ocular aberrations and severity of dry eye symptoms. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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