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

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ClinicalTrials.gov Identifier: NCT03815539
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Tear Film Insufficiency Dry Eye Device: 0.1% sodium hyaluronate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Correlation of Noninvasive Tear Film Function and the Optical Quality in Mild and Moderate Dry Eye
Actual Study Start Date : June 30, 2016
Estimated Primary Completion Date : December 28, 2019
Estimated Study Completion Date : December 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: 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).
Device: 0.1% sodium hyaluronate
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 Measures :
  1. The difference of tear film function as NIBUT by Keratograph 5M between dry eye and normal group [ Time Frame: One day visit ]
    Keratograph 5M was used for NIBUT to test in the dry eye and normal group for tear film function.

  2. The difference of the optical quality as scattering index between dry eye and normal group [ Time Frame: One day visit ]
    The scattering index by OQAS for optical quality was tested in dry eye and normal group.

  3. The correlation of NIBUT and scattering index in normal group [ Time Frame: One day visit ]
    Pearson correlation was tested between NIBUT and scattering index in normal group.

  4. The correlation of NIBUT and scattering index in dry eye group [ Time Frame: One day visit ]
    Pearson correlation was tested between NIBUT and scattering index in dry eye group.

  5. Time changing pattern of NIBUT and scattering index in dry eye group [ Time Frame: base line, 10, 30,60, 90, 120 min after 0.1% sodium hyaluronate instillation ]
    The NIBUT and the scattering index change was tested before and after 0.1% sodium hyaluronate instillation in dry eye group



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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815539


Contacts
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Contact: Henan Zhang, M.D. 86-013632223711 2919941802@qq.com

Locations
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China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Henan Zhang, M.D.    86-013632223711    2919941802@qq.com   
Principal Investigator: Jin Yuan, M.D., Ph.D.         
Sponsors and Collaborators
Jin Yuan

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Responsible Party: Jin Yuan, Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03815539     History of Changes
Other Study ID Numbers: 20181230
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2018

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

Keywords provided by Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University:
dry eye
noninvasive tear breakup time
tear film related optical quality
correlation analysis

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Xerophthalmia
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents