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Wireless Micropump in Dry Eye Patients

Primary Purpose

Dry Eye

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sodium Hyaluronate
Sponsored by
Tianjin Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring micropump, dry eye, sodium hyaluronate

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.)

Sites / Locations

  • Tianjin Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sodium hyaluronate

Arm 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.

Outcomes

Primary Outcome Measures

tear film break-up time
change before and after sodium hyaluronate with OCCULUS
tear film thickness
change before and after sodium hyaluronate with OCCULUS
corneal epithelium defect percentage
change before and after sodium hyaluronate with OCCULUS

Secondary Outcome Measures

Full Information

First Posted
December 8, 2020
Last Updated
December 12, 2020
Sponsor
Tianjin Eye Hospital
Collaborators
Tianjin University
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1. Study Identification

Unique Protocol Identification Number
NCT04667819
Brief Title
Wireless Micropump in Dry Eye Patients
Official Title
Clinical Efficacy of Wireless Micropump in Dry Eye Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Eye Hospital
Collaborators
Tianjin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
micropump, dry eye, sodium hyaluronate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sodium hyaluronate
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Sodium Hyaluronate
Intervention Description
We usage a special type of anterior eye drug delivery system to conduct the transmission of sodium hyaluronate in dry eye patients.
Primary Outcome Measure Information:
Title
tear film break-up time
Description
change before and after sodium hyaluronate with OCCULUS
Time Frame
change from baseline with OCCULUS at 6 months
Title
tear film thickness
Description
change before and after sodium hyaluronate with OCCULUS
Time Frame
change from baseline with OCCULUS at 6 months
Title
corneal epithelium defect percentage
Description
change before and after sodium hyaluronate with OCCULUS
Time Frame
change from baseline with OCCULUS at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Wang, director
Phone
+862227313336
Email
wangyan7143@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Wang, director
Organizational Affiliation
Tianjin Eye Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xuexin Duan, professor
Organizational Affiliation
Tianjin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Eye Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Wang, director
Phone
+86-02227305083
Email
wangyan7143@vip.sina.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22441561
Citation
Resto PJ, Berthier E, Beebe DJ, Williams JC. An inertia enhanced passive pumping mechanism for fluid flow in microfluidic devices. Lab Chip. 2012 Jun 21;12(12):2221-8. doi: 10.1039/c2lc20858j. Epub 2012 Mar 23.
Results Reference
result
PubMed Identifier
28128365
Citation
Kamal T, Watkins R, Cen Z, Rubinstein J, Kong G, Lee WM. Design and fabrication of a passive droplet dispenser for portable high resolution imaging system. Sci Rep. 2017 Jan 27;7:41482. doi: 10.1038/srep41482.
Results Reference
result
PubMed Identifier
15767073
Citation
Kwon JW, Kim JS, Choi SB, Lee JH, Wee WR. Experimental study of an automated system for the delivery of eyedrops using a microinfusion pump. Am J Ophthalmol. 2005 Mar;139(3):547-9. doi: 10.1016/j.ajo.2004.08.051.
Results Reference
result
PubMed Identifier
25188786
Citation
Huang PH, Nama N, Mao Z, Li P, Rufo J, Chen Y, Xie Y, Wei CH, Wang L, Huang TJ. A reliable and programmable acoustofluidic pump powered by oscillating sharp-edge structures. Lab Chip. 2014 Nov 21;14(22):4319-23. doi: 10.1039/c4lc00806e.
Results Reference
result
PubMed Identifier
31083981
Citation
Wu Z, Cai H, Ao Z, Nunez A, Liu H, Bondesson M, Guo S, Guo F. A Digital Acoustofluidic Pump Powered by Localized Fluid-Substrate Interactions. Anal Chem. 2019 Jun 4;91(11):7097-7103. doi: 10.1021/acs.analchem.9b00069. Epub 2019 May 14.
Results Reference
result

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Wireless Micropump in Dry Eye Patients

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