Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us|News
Study on the improvement of visual function and optic disc vessel density in non-acute stage diabetic optic neuropathy by eye acupuncture

Registration number：

ITMCTR2024000532

Date of Last Refreshed on：

2024-10-12

Date of Registration：

2024-10-12

Registration Status：

Retrospective registration

Public title：

Study on the improvement of visual function and optic disc vessel density in non-acute stage diabetic optic neuropathy by eye acupuncture

English Acronym：

Scientific title：

tudy on the improvement of visual function and optic disc vessel density in non-acute stage diabetic optic neuropathy by eye acupuncture

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Liu Ziqiang

Study leader：

Jie Chuanhong

Applicant telephone：

18810959064

Study leader's telephone：

18810959064

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1581248785@qq.com

Study leader's E-mail：

jiechuanhong@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

33 Lugu Road Shijingshan District Beijing

Study leader's address：

33 Lugu Road Shijingshan District Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

China Academy of Chinese Medical Sciences Eye Hospital

Approved by ethic committee：

Approved No. of ethic committee：

YKEC-KT-2024-001-P002

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee Eye Hospital China Academy of Chinese Medical Sciences

Date of approved by ethic committee：

2024/2/4 0:00:00

Contact Name of the ethic committee：

Kang Zefeng

Contact Address of the ethic committee：

33 Lugu Road Shijingshan District Beijing

Contact phone of the ethic committee：

010-68688877-5589

Contact email of the ethic committee：

1581248785@qq.com

Primary sponsor：

China Academy of Chinese Medical Sciences Eye Hospital

Primary sponsor's address：

33 Lugu Road Shijingshan District Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Shijingshan district

Institution
hospital：

Eye hospital China Academy of Chinese Medical Sciences

Address：

33 Lugu Road Shijingshan District Beijing

Source(s) of funding：

Beijing Central Management Bureau and Eye hospital China Academy of Chinese Medical Sciences

Target disease：

Diabetic optic neuropathy

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

To verify the clinical effectiveness and safety of TCM eye acupuncture therapy in treating diabetic optic neuropathy patients with non-acute Qi-deficiency and blood-stasis.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Meet DON non-acute stage staging criteria; (2) Age 40-75 years old; (3) TCM syndrome differentiation of Qi deficiency and blood stasis; (4) signed informed consent.

Exclusion criteria：

(1) Poor refractive interstitial clarity difficult to perform fundus observer; (2) Patients with age-related macular degeneration glaucoma retinal vein obstruction uveitis and other optic nerve diseases; (3) Patients with severe cardiovascular cerebrovascular liver and hematopoietic system diseases; (4) Patients with serious life-threatening primary diseases and mental disorders; (5) Pregnant or lactating women; (6) Participants in other clinical trials; (7) The examination process can not cooperate can not adhere to the tracking of the fundus examination.

Study execute time：

From 2023-09-01

To      2025-08-31

Recruiting time：

From 2024-02-05

To      2025-08-01

Interventions：

30

Group：

Control group

Sample size：

Intervention：

Pseudoacupuncture + basic treatment

Intervention code：

30

Group：

Experimental group

Sample size：

Intervention：

Eye acupuncture + basic treatment

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Shijingshan district

Institution/hospital：

Eye hospital China Academy of Chinese Medical Sciences

Level of the institution：

Third class first class

Outcomes：

Outcome：

Fluorescent fundus angiography

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Mean sensitivity

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Optical coherence tomography angiography

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Non-contact intraocular pressure

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Fundus examination with slit lamp and ophthalmoscope

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Liver and kidney function

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Best corrected visual acuity

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Mean visual field defect

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Recruiting

40
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Table of random numbers

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

No

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data collection was carried out through the case record form and data management was carried out through the establishment of electronic database.

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above