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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
one drop of preservative-free, hypotonic 0.18% sodium hyaluronate in one eye
one drop of sterile 0.9% sodium chloride solution in the other eye
Ramathibodi Hospital
Bangkok, Bangkok, Thailand
Ocular aberrations
A Zywave® II aberrometer which is a wavefront-sensing device based on the Hartmann-Shack principle was used to analyze monochromatic wavefront aberrations of the whole eye.
Time frame: 120 minutes
Severity of dry eye symptoms
Dry eye symptoms in both eyes were graded separately by an interview based on a questionnaire inquiring about 12 symptoms: soreness, scratchiness, dryness, grittiness, burning, itchiness, ocular fatigue, lid heaviness, blurred vision, photophobia, discharge, and excess tearing, using a 0-100 mm visual analogue scale (VAS) (0 = no symptoms to 100 = severe symptoms)
Time frame: 120 minutes
Adverse reactions and complications
Time frame: 120 minutes
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