<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03815539</url>
  </required_header>
  <id_info>
    <org_study_id>20181230</org_study_id>
    <nct_id>NCT03815539</nct_id>
  </id_info>
  <brief_title>Correlation of Noninvasive Tear Film Function and the Optical Quality in Mild and Moderate Dry Eye</brief_title>
  <official_title>Correlation of Noninvasive Tear Film Function and the Optical Quality in Mild and Moderate Dry Eye</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jin Yuan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhongshan Ophthalmic Center, Sun Yat-sen University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      2017 International Dry Eye Workshop (DEWS) defines dry eye as a multifactorial ocular surface&#xD;
      disease characterized by tear film instability with disturbed visual function. As a smooth&#xD;
      transparent structure and the outmost layer of the whole ocular refractive system, tear film&#xD;
      plays an important role. In dry eye, the instability of tear film caused by a lack of tear&#xD;
      volume or high evaporation makes it more vulnerable to break up during blinking intervals,&#xD;
      exposing the rough epithelium of the corneal surface and introducing extra aberrations and&#xD;
      scatter. This would affect image sharpness on the retina and lower the optical quality. Also,&#xD;
      it had been observed that the dynamic tear film scattering was reduced and the objective&#xD;
      optical quality was improved transiently after artificial tears instillation. Though these&#xD;
      findings supported the fact of visual quality impairment in dry eye. It remains unclear how&#xD;
      does the tear film instability affect the visual quality in specific. Whether it lowers the&#xD;
      optical quality of the whole ocular or just affects the tear-film associated part alone and&#xD;
      whether there is a correlation with the tear film function are still unknown and to be&#xD;
      answered. So we wondered whether there is a correlation between the tear film function and&#xD;
      the related optical quality in dry eye. Though it had been inspected that the invasive tear&#xD;
      break up time by fluorescein staining was positively correlated with the related scattering&#xD;
      of tear film. To the newest dry eye diagnosis criteria of 2017 DEWS, the non-invasive tear&#xD;
      break-up time has been amended to the first line instead of the invasive methods, e.g.&#xD;
      fluorescein staining, which was thought to be less accurate and less credible. What's more,&#xD;
      the invasive method of tear film evaluation might introduce confounding factors to the&#xD;
      successive optical quality assessment. So we need a more accurate investigation to the&#xD;
      relationships of the tear film function and the optical quality in dry eye. This study was&#xD;
      intended to measure the non-invasive tear break-up time and the objective optical quality in&#xD;
      normal people and dry eye patients to illustrate this question. In addition, we will&#xD;
      investigate the relation of evolution trends of NIKBUT and objective optical quality under&#xD;
      artificial tears for a better illustration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the 2017 International Dry Eye Workshop (DEWS), dry eye is &quot;a multifactorial&#xD;
      disease of the ocular surface characterized by ocular symptoms, in which tear film&#xD;
      instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory&#xD;
      abnormalities play etiological roles.&quot; Among the various symptoms, blurred vision and vision&#xD;
      fluctuation are quite common, especially after long time reading or screen work. While the&#xD;
      vision discomfort might point to visual quality impairment in dry eye. As the most outlayer&#xD;
      and smooth transparent structure of the ocular, tear film plays an important role in the&#xD;
      whole ocular refraction. In dry eye patients, the instability of tear film caused by lack of&#xD;
      tear volume or high evaporation makes it more vulnerable to break out during blinking&#xD;
      intervals and expose the rough epithelium of the corneal surface, which would introduce extra&#xD;
      aberration and scattering. While the extra scattering would affect the image sharpness&#xD;
      projected to the retina and might lower down the optical quality. Moreover, the more distant&#xD;
      the scattering source, the more effects on retina image and optical quality. Indeed, it had&#xD;
      been proved that compared with normal people, the whole ocular scattering was higher and the&#xD;
      optical quality was lower in dry eye. Also, it had been observed that the dynamic tear film&#xD;
      scattering was reduced and the objective optical quality was improved transiently after&#xD;
      artificial tears instillation. Though these findings supported the fact of visual quality&#xD;
      impairment in dry eye. It remains unclear how does the tear film instability affect the&#xD;
      visual quality in specific. Whether it lowers the optical quality of the whole ocular or just&#xD;
      affects the tear-film associated part alone and whether there is a correlation with the tear&#xD;
      film function are still unknown and to be answered. So we wondered whether there is a&#xD;
      correlation between the tear film function and the related optical quality in dry eye. Though&#xD;
      it had been inspected that the invasive tear break up time by fluorescein staining was&#xD;
      positively correlated with the related scattering of tear film. To the newest dry eye&#xD;
      diagnosis criteria of 2017 DEWS, the non-invasive tear break-up time has been amended to the&#xD;
      first line instead of the invasive methods, e.g. fluorescein staining, which was thought to&#xD;
      be less accurate and less credible. What's more, the invasive method of tear film evaluation&#xD;
      might introduce confounding factors to the successive optical quality assessment. So we need&#xD;
      a more accurate investigation to the relationships of the tear film function and the optical&#xD;
      quality in dry eye. This study was intended to measure the non-invasive tear break-up time&#xD;
      and the objective optical quality in normal people and dry eye patients to illustrate this&#xD;
      question. In addition, we will investigate the relation of evolution trends of NIKBUT and&#xD;
      objective optical quality under artificial tears for a better illustration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 30, 2016</start_date>
  <completion_date type="Anticipated">December 28, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The difference of tear film function as NIBUT by Keratograph 5M between dry eye and normal group</measure>
    <time_frame>One day visit</time_frame>
    <description>Keratograph 5M was used for NIBUT to test in the dry eye and normal group for tear film function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The difference of the optical quality as scattering index between dry eye and normal group</measure>
    <time_frame>One day visit</time_frame>
    <description>The scattering index by OQAS for optical quality was tested in dry eye and normal group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The correlation of NIBUT and scattering index in normal group</measure>
    <time_frame>One day visit</time_frame>
    <description>Pearson correlation was tested between NIBUT and scattering index in normal group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The correlation of NIBUT and scattering index in dry eye group</measure>
    <time_frame>One day visit</time_frame>
    <description>Pearson correlation was tested between NIBUT and scattering index in dry eye group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time changing pattern of NIBUT and scattering index in dry eye group</measure>
    <time_frame>base line, 10, 30,60, 90, 120 min after 0.1% sodium hyaluronate instillation</time_frame>
    <description>The NIBUT and the scattering index change was tested before and after 0.1% sodium hyaluronate instillation in dry eye group</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Tear Film Insufficiency</condition>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>dry eye group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>0.1% sodium hyaluronate</intervention_name>
    <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).</description>
    <arm_group_label>dry eye group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  for dry eye group: Ocular Surface Disease Index (OSDI) between 13 to 32 and NIBUT &lt;10&#xD;
             seconds.&#xD;
&#xD;
          -  for normal group: in absence of ocular symptoms or signs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  opacity of the refractive tissue&#xD;
&#xD;
          -  history of ocular surgery that might affect the tear film (eg, refractive surgery,&#xD;
             punctum plug insertion, etc)&#xD;
&#xD;
          -  best corrected visual acuity of decimal vision &lt; 1.0&#xD;
&#xD;
          -  spherical error ≥ 6 diopters (D)&#xD;
&#xD;
          -  cylindrical error ≤-2.0 D or ≥+2.0D&#xD;
&#xD;
          -  allergy to the 0.1% sodium hyaluronate&#xD;
&#xD;
          -  any condition that might interfere with the optical quality.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Henan Zhang, M.D.</last_name>
    <phone>86-013632223711</phone>
    <email>2919941802@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhongshan Ophthalmic Center, Sun Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Henan Zhang, M.D.</last_name>
      <phone>86-013632223711</phone>
      <email>2919941802@qq.com</email>
    </contact>
    <investigator>
      <last_name>Jin Yuan, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 15, 2018</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Jin Yuan</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>dry eye</keyword>
  <keyword>noninvasive tear breakup time</keyword>
  <keyword>tear film related optical quality</keyword>
  <keyword>correlation analysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    <mesh_term>Xerophthalmia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03815539
org study id: 20181230
nct id: NCT03815539
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: The difference of tear film function as NIBUT by Keratograph 5M between dry eye and normal group
time frame: One day visit
description: Keratograph 5M was used for NIBUT to test in the dry eye and normal group for tear film function.
measure: The difference of the optical quality as scattering index between dry eye and normal group
time frame: One day visit
description: The scattering index by OQAS for optical quality was tested in dry eye and normal group.
measure: The correlation of NIBUT and scattering index in normal group
time frame: One day visit
description: Pearson correlation was tested between NIBUT and scattering index in normal group.
measure: The correlation of NIBUT and scattering index in dry eye group
time frame: One day visit
description: Pearson correlation was tested between NIBUT and scattering index in dry eye group.
measure: 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
description: The NIBUT and the scattering index change was tested before and after 0.1% sodium hyaluronate instillation in dry eye group
arm group label: dry eye group
arm group type: Experimental
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: 0.1% sodium hyaluronate
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).
arm group label: dry eye group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Henan Zhang, M.D.
phone: 86-013632223711
email: 2919941802@qq.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
investigator full name: Jin Yuan
investigator title: Professor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Xerophthalmia
mesh term: Hyaluronic Acid