MedTrace Logo

Sodium Hyaluronate and Wavefront Aberrations in Dry Eyes

NCT01363414 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-06-01

No results posted yet for this study

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.

Conditions

  • Dry Eye

Interventions

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

Sponsors & Collaborators

  • Ramathibodi Hospital

    lead OTHER

Principal Investigators

  • Kaevalin Lekhnaont, MD · Ramathibodi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2010-06-30
Completion
2010-09-30

Countries

  • Thailand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01363414 on ClinicalTrials.gov