Wireless Micropump in Dry Eye Patients

Tianjin Eye Hospital

Status: Unknown

Conditions: Dry Eye

Treatments: Drug: Sodium Hyaluronate

Study type: Interventional

Funder types: Other

Identifiers

NCT04667819

202076

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

sodium hyaluronate

Experimental group

Description:

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.

Treatment:

Drug: Sodium Hyaluronate