Wireless Micropump in Dry Eye Patients

Dry Eye Clinical Trial

Official title:

Clinical Efficacy of Wireless Micropump in Dry Eye Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04667819
• Other study ID #: 202076
• Status: Recruiting
• Phase: N/A
• Start date: December 2020
• Est. completion date: March 2022

Study information

• Verified date: December 2020
• Source: Tianjin Eye Hospital
• Contact: Yan Wang, director
• Phone: +862227313336
• Email: wangyan7143[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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.

Locations

Country	Name	City	State
China	Tianjin Eye Hospital	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Eye Hospital	Tianjin University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tear film break-up time	change before and after sodium hyaluronate with OCCULUS	change from baseline with OCCULUS at 6 months
Primary	tear film thickness	change before and after sodium hyaluronate with OCCULUS	change from baseline with OCCULUS at 6 months
Primary	corneal epithelium defect percentage	change before and after sodium hyaluronate with OCCULUS	change from baseline with OCCULUS at 6 months