Dry Eye Evaluation System Based on Bioinformatics

Dry Eye Clinical Trial

Official title:

Dry Eye Evaluation System Based on Bioinformatics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04109170
• Other study ID #: FSHX2019-01
• Status: Recruiting
• Start date: September 23, 2019
• Est. completion date: January 23, 2020

Study information

• Verified date: September 2019
• Source: Huaxia Eye Hospital Group
• Contact: Chi Zhang, PhD,MD
• Phone: +86(757)83908467
• Email: zhangc94[@]huaxiaeye.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 23, 2020
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 90 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Dye Eye

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Locations

Country	Name	City	State
China	Huaxia Eye Hosptial of Foshan	Foshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Huaxia Eye Hospital Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 2 months
Primary	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.	up to 2 months
Primary	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).	up to 2 months
Primary	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.	up to 2 months
Secondary	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.	up to 2 months