Tear Film InsufficiencyNCT03815539
Correlation of Noninvasive Tear Film Function and the Optical Quality in Mild and Moderate Dry Eye
A study testing 0.1% sodium hyaluronate in people with Tear Film Insufficiency and Dry Eye, run by Jin Yuan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tear Film Insufficiency, Dry Eye
- What is being tested?
- 0.1% sodium hyaluronate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2016to 28 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Henan Zhang, M.D., 86-013632223711, 2919941802@qq.com
Jin Yuan, M.D., Ph.D.
About this study
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.
Read the 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.
- Conditions
- Tear Film Insufficiency, Dry Eye
- Being tested
- 0.1% sodium hyaluronate
- Keywords
- dry eye, noninvasive tear breakup time, tear film related optical quality, correlation analysis
- Medical subject headings
- Xerophthalmia, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% sodium hyaluronateDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: 0.1% sodium hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: base line, 10, 30,60, 90, 120 min after 0.1% sodium hyaluronate instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start30 Jun 2016
- Primary completion28 Dec 2019 (estimated)
- Study completion28 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tear Film InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815539
- Sponsor's protocol ID
- 20181230
- Status last verified
- Jan 2018
- First submitted
- 15 Jan 2018
- Last updated
- 24 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Noninvasive Tear Film Function and the Optical Quality in Mild and Moderate Dry Eye
- ClinicalTrials.gov ID
- NCT03815539
- Acronym / sponsor ID
- 20181230
- Conditions
- Tear Film Insufficiency, Dry Eye
- Keywords
- dry eye, noninvasive tear breakup time, tear film related optical quality, correlation analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jin YuanUniversity, hospital or other
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 28 Dec 2019 (estimated)
- Study completion
- 28 Dec 2019 (estimated)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dry eye group | Experimental | Device: 0.1% sodium hyaluronatePart 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). |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.1% sodium hyaluronateIn 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 | dry eye group |
Primary outcome
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.
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.
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.
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.1% sodium hyaluronate in people with Tear Film Insufficiency and Dry Eye, run by Jin Yuan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henan Zhang, M.D. (86-013632223711, 2919941802@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of tear film function as NIBUT by Keratograph 5M between dry eye and normal group (time frame: One day visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.