Wireless Micropump in Dry Eye Patients

Sponsor

Tianjin Eye Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04667819

Collaborator

Tianjin University (Other)

Enrollment

Location

Arm

14.9

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: Sodium Hyaluronate	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Efficacy of Wireless Micropump in Dry Eye Patients

Anticipated Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Sodium Hyaluronate We usage a special type of anterior eye drug delivery system to conduct the transmission of sodium hyaluronate in dry eye patients.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Sodium Hyaluronate

We usage a special type of anterior eye drug delivery system to conduct the transmission of sodium hyaluronate in dry eye patients.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.)