NCT01363414

Sodium Hyaluronate and Wavefront Aberrations in Dry Eyes

Randomized Controlled Trial of the Effects of Sodium Hyaluronate on Wavefront Aberrations in Dry Eye Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Ramathibodi Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Parameters used to determine treatment outcomes included ocular aberrations and severity of dry eye symptoms.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	0.18% sodium hyaluronate	one drop of preservative-free, hypotonic 0.18% sodium hyaluronate in one eye
DRUG	0.9% sodium chloride solution	one drop of sterile 0.9% sodium chloride solution in the other eye

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-06-01
• Completion: 2010-09-01
• First posted: 2011-06-01
• Last updated: 2011-06-01

Locations

1 site across 1 country: Thailand