Wireless Micropump in Dry Eye Patients

NCT04667819 | Unknown DMC

• 1 other identifier: 202076
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Keywords

micropump; dry eye; sodium hyaluronate

Outcome Measures

Primary Outcomes (3)

• tear film break-up time

  change before and after sodium hyaluronate with OCCULUS

  change from baseline with OCCULUS at 6 months

• tear film thickness

  change before and after sodium hyaluronate with OCCULUS

  change from baseline with OCCULUS at 6 months

• corneal epithelium defect percentage

  change before and after sodium hyaluronate with OCCULUS

  change from baseline with OCCULUS at 6 months

Study Arms (1)

sodium hyaluronate

EXPERIMENTAL

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.

Drug: Sodium Hyaluronate

Interventions

Sodium Hyaluronate DRUG

We usage a special type of anterior eye drug delivery system to conduct the transmission of sodium hyaluronate in dry eye patients.

sodium hyaluronate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Tianjin Eye Hospital: lead
• Tianjin University: collaborator

Study Sites (1)

Tianjin Eye Hospital

Tianjin, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 22441561 RESULT

• 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.

  PMID: 28128365 RESULT

• 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.

  PMID: 15767073 RESULT

• 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.

  PMID: 25188786 RESULT

• 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.

  PMID: 31083981 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Yan Wang, director

  Tianjin Eye Hospital

  STUDY DIRECTOR

• Xuexin Duan, professor

  Tianjin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Wang, director

CONTACT

+862227313336; wangyan7143@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)