Wireless Micropump in Dry Eye Patients

Not Applicable

• Conditions: Dry Eye
• Interventions: Drug: Sodium Hyaluronate

• Registration Number: NCT04667819
• Lead Sponsor: Tianjin Eye Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-12
• Study Start: 2020-12
• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-12
• Last Update Submitted: 2020-12-12
• Study First Posted: 2020-12-16
• Last Update Posted: 2020-12-16
• Primary Completion: 2021-12
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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;

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sodium hyaluronate	Sodium Hyaluronate	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.

Primary Outcome Measures

Name	Time	Method
tear film break-up time	change from baseline with OCCULUS at 6 months	change before and after sodium hyaluronate with OCCULUS
tear film thickness	change from baseline with OCCULUS at 6 months	change before and after sodium hyaluronate with OCCULUS
corneal epithelium defect percentage	change from baseline with OCCULUS at 6 months	change before and after sodium hyaluronate with OCCULUS

Trial Locations

Locations (1)

Tianjin Eye Hospital; 🇨🇳 Tianjin, China