Dry EyeNCT04109170
Dry Eye Evaluation System Based on Bioinformatics
An observational study of Dry Eye, run by Huaxia Eye Hospital Group at 1 site in China.
Trial summary
Dry eye is a common ocular surface disease of multifactorial etiology characterized by elevated tear osmolality and inflammation leading to a disrupted ocular surface. The latter is a risk factor for ocular surface infection, yet overt infection is not commonly seen clinically in the typical dry eye patient. Read more about this study
- Who is it for?
- Ages 10 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2019to 23 Jan 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 10 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: People who meet the experimental conditions among the outpatients in our hospital will be selected into the group
Who may be able to join
- Clinical diagnosis of Dye Eye
Who cannot join
- systemic disease (such as diabetes, glaucoma, or systemic collagen vascular disease), ocular disease, a history of tear supplement usage or contact lens wear during the past year,and pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huaxia Eye Hosptial of Foshan
Foshan, Guangdong, 528000
Chi Zhang, MD,PhD, +86(757)83908461, zhangc94@huaxiaeye.com
About this study
Dry eye is a common ocular surface disease of multifactorial etiology characterized by elevated tear osmolality and inflammation leading to a disrupted ocular surface. The latter is a risk factor for ocular surface infection, yet overt infection is not commonly seen clinically in the typical dry eye patient. This suggests that important innate mechanisms operate to protect the dry eye from invading pathogens. Understand the pathogenesis of dry eye will be the measure to prevention and treatment of dry eye.
In this essay, the investigators use the data of experiment in the patients with dry eye and normal, acquire their tear production, tear film stability, and surface damage. The investigators use weka to calculate the prediction accuracy of the 6 algorithm and select the best one, optimize the parameters to get the final prediction accuracy.
- Conditions
- Dry Eye
- Keywords
- Dry Eye, Bioinformatics, Data mining
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dry Eye Group | This group of subjects were diagnosed with dry eye. | |
| Normal Control Group | This group of subjects had no dry eye symptoms and signs and belonged to the normal control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI
The Ocular Surface Disease Index (OSDI; Allergan Inc., Irvine, CA)consists of a 12-item questionnaire and is used to assess dry eye disease; the OSDI questions are drawn from three different categories: vision-related functions, ocular symptoms and environmental triggers. The OSDI is scored on a 4-point scale from 0 (indicating no problems) to 4 (indicating a significant problem). Responses to all of the questions are combined to generate a composite OSDI score that ranges from 0 to 100, with higher OSDI scores representing greater disability. Subjects were asked questions regarding the dry eye symptoms that they experience.
Measured: up to 2 months
Schirmer I test
The Schirmer I test (SIT) without anesthesia for tear secretion function was conducted by placing a 30-mm sterile Schirmer Tear Test strip into the junction of the middle and lateral thirds of the inferior fornix of each eye for 5 minutes. The wet portion of the strip was subsequently measured, with lower scores indicating less tear production.
Measured: up to 2 months
Fluorescein staining
The cornea was divided into upper, lower, nasal, temporal and central zones. Superficial punctate keratopathy (SPK) in the cornea was scored from 0 to 3 in each area. Where 0 indicated no staining in the cornea; 1,<5 punctate stains; 2,5-10 punctate stains; and 3,>10 or filamentous staining detected. The total score was recorded by adding the scores of the five zones for each eye (range: 0-15).
Measured: up to 2 months
Noninvasive Tear Breakup Time
Noninvasive Tear Breakup Time (NI-TBUT) measurements of subjects' eyes were obtained by Keratograph 5. At the start of the recording, the patients were asked to blink three times and then keep their eyes open as long as possible. Irregularities in the reflected image indicated the instability of the tear film. Meanwhile, the examination was recorded on video and a single eye of each subject was assessed three times. All the tests were performeded the same temperature and humidity conditions.
Measured: up to 2 months
Secondary outcomes (1)
Tear meniscus height
Tear meniscus height was also performed by the Keratograph 5 and the image of tear meniscus height was obtained by the instrument. The observer measured the tear meniscus height the center of the lower lid margin. This evaluation was taken three times and the average value was recorded.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start23 Sep 2019
- Primary completion23 Dec 2019 (estimated)
- Study completion23 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Huaxia Eye Hospital Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi Zhang, PhD,MD, Principal investigator, Huaxia Eye Hospital of Foshan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109170
- Sponsor's protocol ID
- FSHX2019-01
- Status last verified
- Sep 2019
- First submitted
- 24 Sep 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Eye Evaluation System Based on Bioinformatics
- ClinicalTrials.gov ID
- NCT04109170
- Acronym / sponsor ID
- FSHX2019-01
- Conditions
- Dry Eye
- Keywords
- Dry Eye, Bioinformatics, Data mining
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Huaxia Eye Hospital GroupUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 23 Dec 2019 (estimated)
- Study completion
- 23 Jan 2020 (estimated)
- First posted
- 30 Sep 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.
Dry eye is a common ocular surface disease of multifactorial etiology characterized by elevated tear osmolality and inflammation leading to a disrupted ocular surface. The latter is a risk factor for ocular surface infection, yet overt infection is not commonly seen clinically in the typical dry eye patient. This suggests that important innate mechanisms operate to protect the dry eye from invading pathogens. Understand the pathogenesis of dry eye will be the measure to prevention and treatment of dry eye.
In this essay, the investigators use the data of experiment in the patients with dry eye and normal, acquire their tear production, tear film stability, and surface damage. The investigators use weka to calculate the prediction accuracy of the 6 algorithm and select the best one, optimize the parameters to get the final prediction accuracy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Eye Group | – | –This group of subjects were diagnosed with dry eye. |
| Normal Control Group | – | –This group of subjects had no dry eye symptoms and signs and belonged to the normal control group. |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People who meet the experimental conditions among the outpatients in our hospital will be selected into the group
Key inclusion criteria (1 listed)
- Clinical diagnosis of Dye Eye
Key exclusion criteria (1 listed)
- systemic disease (such as diabetes, glaucoma, or systemic collagen vascular disease), ocular disease, a history of tear supplement usage or contact lens wear during the past year,and pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
OSDI
Time frame: up to 2 months
The Ocular Surface Disease Index (OSDI; Allergan Inc., Irvine, CA)consists of a 12-item questionnaire and is used to assess dry eye disease; the OSDI questions are drawn from three different categories: vision-related functions, ocular symptoms and environmental triggers. The OSDI is scored on a 4-point scale from 0 (indicating no problems) to 4 (indicating a significant problem). Responses to all of the questions are combined to generate a composite OSDI score that ranges from 0 to 100, with higher OSDI scores representing greater disability. Subjects were asked questions regarding the dry eye symptoms that they experience.
Schirmer I test
Time frame: up to 2 months
The Schirmer I test (SIT) without anesthesia for tear secretion function was conducted by placing a 30-mm sterile Schirmer Tear Test strip into the junction of the middle and lateral thirds of the inferior fornix of each eye for 5 minutes. The wet portion of the strip was subsequently measured, with lower scores indicating less tear production.
Fluorescein staining
Time frame: up to 2 months
The cornea was divided into upper, lower, nasal, temporal and central zones. Superficial punctate keratopathy (SPK) in the cornea was scored from 0 to 3 in each area. Where 0 indicated no staining in the cornea; 1,<5 punctate stains; 2,5-10 punctate stains; and 3,>10 or filamentous staining detected. The total score was recorded by adding the scores of the five zones for each eye (range: 0-15).
Noninvasive Tear Breakup Time
Time frame: up to 2 months
Noninvasive Tear Breakup Time (NI-TBUT) measurements of subjects' eyes were obtained by Keratograph 5. At the start of the recording, the patients were asked to blink three times and then keep their eyes open as long as possible. Irregularities in the reflected image indicated the instability of the tear film. Meanwhile, the examination was recorded on video and a single eye of each subject was assessed three times. All the tests were performeded the same temperature and humidity conditions.
1 secondary outcome
Tear meniscus height
Time frame: up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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.
Chi Zhang, PhD,MD principal investigator
Huaxia Eye Hospital of Foshan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by Huaxia Eye Hospital Group 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 1 inclusion and 1 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 30 Sep 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 Chi Zhang, PhD,MD (+86(757)83908467, zhangc94@huaxiaeye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI (time frame: up to 2 months). The study lists 4 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 30 Sep 2019.