Dry Eye Evaluation System Based on Bioinformatics

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 Overview

• Status: Unknown
• Conditions: Dry Eye

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Chi Zhang, PhD,MD; Phone Number: +86(757)83908467; Email: zhangc94@huaxiaeye.com
• Study Contact Backup: Name: Gangping Zhao, MD; Phone Number: +86(757)83903600; Email: gpzhao@126.com

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Recruiting
      • Huaxia Eye Hosptial of Foshan
      • Contact: Chi Zhang, MD,PhD; Phone Number: +86(757)83908461; Email: zhangc94@huaxiaeye.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 90 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

People who meet the experimental conditions among the outpatients in our hospital will be selected into the group

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Huaxia Eye Hospital Group
• Investigators: Principal Investigator: Chi Zhang, PhD,MD, Huaxia Eye Hospital of Foshan

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 23, 2019
• Primary Completion (ANTICIPATED): December 23, 2019
• Study Completion (ANTICIPATED): January 23, 2020

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (ACTUAL): September 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Dry Eye; Data mining; Bioinformatics
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: FSHX2019-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No