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

NCT03815539 | Unknown

• 1 other identifier: 20181230
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tear Film Insufficiency; Dry Eye

Keywords

dry eye; noninvasive tear breakup time; tear film related optical quality; correlation analysis

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

dry eye group

EXPERIMENTAL

Part of the subjects will be instilled with one drop of 0.1% sodium hyaluronate in one of their eyes, then they will be tested with the devices of Oculus Keratograph 5M and Optical Quality Analysis SystemⅡ at different time points (10min, 30min, 60min, 90min and 120min).

Device: 0.1% sodium hyaluronate

Interventions

0.1% sodium hyaluronate DEVICE

In dry eye group, part of the subjects will be instilled with one drop of 0.1% sodium hyaluronate in one of their eyes, then they will be tested with the devices of Oculus Keratograph 5M and Optical Quality Analysis SystemⅡ at different time points (10min, 30min, 60min, 90min and 120min).

dry eye group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jin Yuan: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Xerophthalmia; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Central Study Contacts

Henan Zhang, M.D.

CONTACT

86-013632223711; 2919941802@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: January 24, 2019
• Study Start: June 30, 2016
• Primary Completion: December 28, 2019
• Study Completion: December 28, 2019
• Last Updated: January 24, 2019

Record last verified: 2018-01

Locations

CN (1)