Clinical trial NCT04667819: Wireless Micropump in Dry Eye Patients
Official title: Clinical Efficacy of Wireless Micropump in Dry Eye Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye
Keywords: micropump
dry eye
sodium hyaluronate
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin University
First posted: 2020-12-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: tear film break-up time
timeFrame: change from baseline with OCCULUS at 6 months
measure: tear film thickness
timeFrame: change from baseline with OCCULUS at 6 months
measure: corneal epithelium defect percentage
timeFrame: change from baseline with OCCULUS at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
Study officials:
affiliation: Tianjin Eye Hospital
name: Yan Wang, director
role: STUDY_DIRECTOR
affiliation: Tianjin University
name: Xuexin Duan, professor
role: PRINCIPAL_INVESTIGATOR
References:
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