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Wireless Micropump in Dry Eye Patients

NCT ID: NCT04667819

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-31

Study Completion Date

2022-03-31

Brief Summary

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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

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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.

Conditions

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Dry Eye

Keywords

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micropump dry eye sodium hyaluronate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sodium hyaluronate

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.

Group Type EXPERIMENTAL

Sodium Hyaluronate

Intervention Type DRUG

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

Interventions

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Sodium Hyaluronate

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

Intervention Type DRUG

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tianjin University

OTHER

Sponsor Role collaborator

Tianjin Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Wang, director

Role: STUDY_DIRECTOR

Tianjin Eye Hospital

Xuexin Duan, professor

Role: PRINCIPAL_INVESTIGATOR

Tianjin University

Locations

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Tianjin Eye Hospital

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yan Wang, director

Role: CONTACT

Phone: +862227313336

Email: [email protected]

Facility Contacts

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Yan Wang, director

Role: primary

References

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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.

Reference Type RESULT
PMID: 22441561 (View on PubMed)

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.

Reference Type RESULT
PMID: 28128365 (View on PubMed)

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.

Reference Type RESULT
PMID: 15767073 (View on PubMed)

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.

Reference Type RESULT
PMID: 25188786 (View on PubMed)

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.

Reference Type RESULT
PMID: 31083981 (View on PubMed)

Other Identifiers

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202076

Identifier Type: -

Identifier Source: org_study_id