Dry Eye
Conditions
Keywords
micropump, dry eye, sodium hyaluronate
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.
Interventions
DRUGSodium Hyaluronate
We usage a special type of anterior eye drug delivery system to conduct the transmission of sodium hyaluronate in dry eye patients.
Sponsors
Tianjin University
Tianjin Eye Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactYan Wang, director
Outcome results
None listed