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Clinical Trial 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.


Clinical Trial Description

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


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01363414
Study type Interventional
Source Ramathibodi Hospital
Contact
Status Completed
Phase N/A
Start date January 2007
Completion date September 2010

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