NCT03815539

Correlation of Noninvasive Tear Film Function and the Optical Quality in Mild and Moderate Dry Eye

Status unknown NA Last updated 24 January 2019

What this trial tests

NA trial testing 0.1% sodium hyaluronate in Tear Film Insufficiency in 80 participants. Status unknown.

Timeline

30 June 2016

Primary endpoint
28 December 2019

28 December 2019

Quick facts

Lead sponsor	Jin Yuan
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	80
Start date	30 June 2016
Primary completion	28 December 2019
Estimated completion	28 December 2019
Sites	1 location across China

Drugs / interventions tested

• 0.1% sodium hyaluronate

Conditions studied

• Tear Film Insufficiency — all drugs for Tear Film Insufficiency →
• Dry Eye — all drugs for Dry Eye →

Sponsor

Jin Yuan

Who can join

Adults 20 to 55, any sex, with Tear Film Insufficiency or Dry Eye. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

2017 International Dry Eye Workshop (DEWS) defines dry eye as a multifactorial ocular surface disease characterized by tear film instability with disturbed visual function. As a smooth transparent structure and the outmost layer of the whole ocular refractive system, tear film plays an important role. In dry eye, the instability of tear film caused by a lack of tear volume or high evaporation makes it more vulnerable to break up during blinking intervals, exposing the rough epithelium of the corneal surface and introducing extra aberrations and scatter. This would affect image sharpness on the retina and lower the optical quality. Also, it had been observed that the dynamic tear film scattering was reduced and the objective optical quality was improved transiently after artificial tears instillation. Though these findings supported the fact of visual quality impairment in dry eye. It remains unclear how does the tear film instability affect the visual quality in specific. Whether it lowers the optical quality of the whole ocular or just affects the tear-film associated part alone and whether there is a correlation with the tear film function are still unknown and to be answered. So we wondered whether there is a correlation between the tear film function and the related optical quality in dry eye. Though it had been inspected that the invasive tear break up time by fluorescein staining was positively correlated with the related scattering of tear film. To the newest dry eye diagnosis criteria of 2017 DEWS, the non-invasive tear break-up time has been amended to the first line instead of the invasive methods, e.g. fluorescein staining, which was thought to be less accurate and less credible. What's more, the invasive method of tear film evaluation might introduce confounding factors to the successive optical quality assessment. So we need a more accurate investigation to the relationships of the tear film function and the optical quality in dry eye. This study was intended to measure the non-invasive tear break-up time and the objective optical quality in normal people and dry eye patients to illustrate this question. In addition, we will investigate the relation of evolution trends of NIKBUT and objective optical quality under artificial tears for a better illustration.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.