Wireless Micropump in Dry Eye Patients

Study Overview
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Brief Summary
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The purpose of this study is to carry out a trial to get more convincing and valuable results of the wireless micropump in dry eye patients and compare the outcomes before and after eye drops usage. The investigators hope to investigate the micropump comprehensively, including the comparison of tear film break-up time, corneal epithelium defect percentage, and tear film thickness. To meet the demands of a trial, all the examination equipment should be the same for each patient, and this will limit the variations within a study.

Detailed Description
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The purpose of this study is to carry out a trial to get more convincing and valuable results of the wireless micropump in dry eye patients and compare the outcomes before and after eye drops usage. The investigators hope to investigate the micropump comprehensively, including the comparison of tear film break-up time, corneal epithelium defect percentage, and tear film thickness. To meet the demands of a trial, all the examination equipment and methods should be the same for each patient, and this will limit the variations within a study.

Official Title
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Clinical Efficacy of Wireless Micropump in Dry Eye Patients

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: Sodium Hyaluronate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elimination of serious mental and psychological diseases; be accompanied by a parent or guardian who is able to give informed consent as demonstrated by signing a record of informed consent; be willing to comply with the clinical trial visit schedule as directed by the investigator; at baseline, be within the age range of 18 to 80 years old inclusive; BCVA≥1.0 of both eyes for each patient; dry eye test is BUT<5s and or Schimer test<5mm/5min； without other ophthalmic diseases; Exclusion Criteria: At the same time, patients with other eye diseases (such as glaucoma, corneal opacity, uveitis, etc.) were diagnosed; serious mental and psychological diseases; history of refractive surgery; nystagmus or failure to cooperate; history of intraocular surgery; patients with systemic diseases (such as diabetes, hypertension, heart disease, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sodium hyaluronate<br>Sodium hyaluronate has become a novel and effective eye drop for the treatment of the dry eye. However, we design a special method of usage of sodium hyaluronate in dry eye patients. | Drug: Sodium Hyaluronate<br>* We usage a special type of anterior eye drug delivery system to conduct the transmission of sodium hyaluronate in dry eye patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tear film break-up time | change before and after sodium hyaluronate with OCCULUS | change from baseline with OCCULUS at 6 months | 
| tear film thickness | change before and after sodium hyaluronate with OCCULUS | change from baseline with OCCULUS at 6 months | 
| corneal epithelium defect percentage | change before and after sodium hyaluronate with OCCULUS | change from baseline with OCCULUS at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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micropump, dry eye, sodium hyaluronate