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

Primary Purpose

Tear Film Insufficiency, Dry Eye

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
0.1% sodium hyaluronate
Sponsored by
Jin Yuan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Tear Film Insufficiency focused on measuring dry eye, noninvasive tear breakup time, tear film related optical quality, correlation analysis

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dry eye group

Arm Description

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).

Outcomes

Primary Outcome Measures

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.
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.
The correlation of NIBUT and scattering index in normal group
Pearson correlation was tested between NIBUT and scattering index in normal group.
The correlation of NIBUT and scattering index in dry eye group
Pearson correlation was tested between NIBUT and scattering index in dry eye group.
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

Secondary Outcome Measures

Full Information

First Posted
January 15, 2018
Last Updated
January 23, 2019
Sponsor
Jin Yuan
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1. Study Identification

Unique Protocol Identification Number
NCT03815539
Brief Title
Correlation of Noninvasive Tear Film Function and the Optical Quality in Mild and Moderate Dry Eye
Official Title
Correlation of Noninvasive Tear Film Function and the Optical Quality in Mild and Moderate Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2016 (Actual)
Primary Completion Date
December 28, 2019 (Anticipated)
Study Completion Date
December 28, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jin Yuan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
According to the 2017 International Dry Eye Workshop (DEWS), dry eye is "a multifactorial disease of the ocular surface characterized by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles." Among the various symptoms, blurred vision and vision fluctuation are quite common, especially after long time reading or screen work. While the vision discomfort might point to visual quality impairment in dry eye. As the most outlayer and smooth transparent structure of the ocular, tear film plays an important role in the whole ocular refraction. In dry eye patients, the instability of tear film caused by lack of tear volume or high evaporation makes it more vulnerable to break out during blinking intervals and expose the rough epithelium of the corneal surface, which would introduce extra aberration and scattering. While the extra scattering would affect the image sharpness projected to the retina and might lower down the optical quality. Moreover, the more distant the scattering source, the more effects on retina image and optical quality. Indeed, it had been proved that compared with normal people, the whole ocular scattering was higher and the optical quality was lower in dry eye. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tear Film Insufficiency, Dry Eye
Keywords
dry eye, noninvasive tear breakup time, tear film related optical quality, correlation analysis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dry eye group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
0.1% sodium hyaluronate
Intervention Description
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).
Primary Outcome Measure Information:
Title
The difference of tear film function as NIBUT by Keratograph 5M between dry eye and normal group
Description
Keratograph 5M was used for NIBUT to test in the dry eye and normal group for tear film function.
Time Frame
One day visit
Title
The difference of the optical quality as scattering index between dry eye and normal group
Description
The scattering index by OQAS for optical quality was tested in dry eye and normal group.
Time Frame
One day visit
Title
The correlation of NIBUT and scattering index in normal group
Description
Pearson correlation was tested between NIBUT and scattering index in normal group.
Time Frame
One day visit
Title
The correlation of NIBUT and scattering index in dry eye group
Description
Pearson correlation was tested between NIBUT and scattering index in dry eye group.
Time Frame
One day visit
Title
Time changing pattern of NIBUT and scattering index in dry eye group
Description
The NIBUT and the scattering index change was tested before and after 0.1% sodium hyaluronate instillation in dry eye group
Time Frame
base line, 10, 30,60, 90, 120 min after 0.1% sodium hyaluronate instillation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henan Zhang, M.D.
Phone
86-013632223711
Email
2919941802@qq.com
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henan Zhang, M.D.
Phone
86-013632223711
Email
2919941802@qq.com
First Name & Middle Initial & Last Name & Degree
Jin Yuan, M.D., Ph.D.

12. IPD Sharing Statement

Learn more about this trial

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

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