Dry Eye Evaluation System Based on Bioinformatics

NCT04109170 | Unknown

• 1 other identifier: FSHX2019-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye

Keywords

Dry Eye; Bioinformatics; Data mining

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Tear meniscus height

  up to 2 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 10 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Clinical diagnosis of Dye Eye

You may not qualify if:

• 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

Sponsors & Collaborators

• Huaxia Eye Hospital Group: lead

Study Sites (1)

Huaxia Eye Hosptial of Foshan

Foshan, Guangdong, 528000, China

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Chi Zhang, PhD,MD

  Huaxia Eye Hospital of Foshan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi Zhang, PhD,MD

CONTACT

+86(757)83908467; zhangc94@huaxiaeye.com

Gangping Zhao, MD

CONTACT

+86(757)83903600; gpzhao@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 30, 2019
• Study Start: September 23, 2019
• Primary Completion: December 23, 2019
• Study Completion: January 23, 2020
• Last Updated: September 30, 2019

Record last verified: 2019-09

Locations

CN (1)