Dry Eye Clinical Trial
Official title:
Correlation of Noninvasive Tear Film Function and the Optical Quality in Mild and Moderate Dry Eye
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 28, 2019 |
Est. primary completion date | December 28, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 55 Years |
Eligibility |
Inclusion Criteria: - for dry eye group: Ocular Surface Disease Index (OSDI) between 13 to 32 and NIBUT <10 seconds. - for normal group: in absence of ocular symptoms or signs. Exclusion Criteria: - opacity of the refractive tissue - history of ocular surgery that might affect the tear film (eg, refractive surgery, punctum plug insertion, etc) - best corrected visual acuity of decimal vision < 1.0 - spherical error = 6 diopters (D) - cylindrical error =-2.0 D or =+2.0D - allergy to the 0.1% sodium hyaluronate - any condition that might interfere with the optical quality. |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Ophthalmic Center, Sun Yat-Sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Jin Yuan |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The difference of tear film function as NIBUT by Keratograph 5M between dry eye and normal group | Keratograph 5M was used for NIBUT to test in the dry eye and normal group for tear film function. | One day visit | |
Primary | The difference of the optical quality as scattering index between dry eye and normal group | The scattering index by OQAS for optical quality was tested in dry eye and normal group. | One day visit | |
Primary | The correlation of NIBUT and scattering index in normal group | Pearson correlation was tested between NIBUT and scattering index in normal group. | One day visit | |
Primary | The correlation of NIBUT and scattering index in dry eye group | Pearson correlation was tested between NIBUT and scattering index in dry eye group. | One day visit | |
Primary | Time changing pattern of NIBUT and scattering index in dry eye group | The NIBUT and the scattering index change was tested before and after 0.1% sodium hyaluronate instillation in dry eye group | base line, 10, 30,60, 90, 120 min after 0.1% sodium hyaluronate instillation |
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