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Clinical Trials/NCT04109170
NCT04109170
Unknown
Not Applicable

Dry Eye Evaluation System Based on Bioinformatics

Huaxia Eye Hospital Group1 site in 1 country500 target enrollmentSeptember 23, 2019
ConditionsDry Eye

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dry Eye
Sponsor
Huaxia Eye Hospital Group
Enrollment
500
Locations
1
Primary Endpoint
OSDI
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 23, 2019
End Date
January 23, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Huaxia Eye Hospital Group
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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).

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.

Secondary Outcomes

  • Tear meniscus height(up to 2 months)

Study Sites (1)

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