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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03021629
Other study ID # tjykdxykyy6
Secondary ID
Status Completed
Phase N/A
First received January 13, 2017
Last updated July 13, 2017
Start date July 2013
Est. completion date December 2016

Study information

Verified date July 2017
Source Tianjin Medical University Eye Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Vitamin D deficiency is known to be significantly associated with high myopia. This study investigated the vitamin D status in patients with high myopia and primary open-angle glaucoma, in order to understand the relationship between high myopia and the development of primary open-angle glaucoma.110 primary open-angle glaucoma patients, 110 high myopia patients and 110 age-matched people in the Han population were enrolled. Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay.Vitamin D receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment length polymorphism technique.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 65 Years
Eligibility Inclusion Criteria:

-primary open-angle glaucoma (1) intraocular pressure above 21 mmHg or more in each eye without therapy; (2) wide anterior chamber angle; (3)glaucomatous optic neuropathy (Glaucomatous optic nerve damage was defined as cup-to-disc ratio higher than 0.7 or focal loss of the nerve fiber layer (notch) associated with a consistent glaucomatous visual field defect in at least one eye;(4) visual field loss consistent with optic nerve damage and visual fields were performed by using standard automated perimetry in at least one eye.

c(with refractive error >6D) were recruited.

Exclusion Criteria:

- the presence of any secondary glaucoma with an exfoliation syndrome or a history of ocular trauma, high myopia, macular degeneration, other ocular diseases, and also a known history of systemic diseases and administration of vitamin D3 or other analog.

High myopia patients with ocular disease such as glaucoma, a history of administration of vitamin D3 or other analog or a history of retinopathy or connective tissue disorders associated with myopia, such as Stickler or Marfan syndromes, were not included.

Study Design


Intervention

Other:
Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay


Locations

Country Name City State
China Tianjin Medical University Eye Hospital Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Lv Yingjuan

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum levels of 1a, 25-Dihydroxyvitamin D3 1 day visit
Secondary gene polymorphisms of vitamin D receptor 1 day visit
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