Comparison of Vitamin D Status and Vitamin D Receptor Polymorphisms in Patients With High Myopia and Primary Open-angle Glaucoma

Sponsor

Lv Yingjuan (Other)

Overall Status

Completed

CT.gov ID

NCT03021629

Collaborator

(none)

500

Enrollment

Location

Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency Primary Open-angle Glaucoma High Myopia Vitamin D Receptor Polymorphisms	Other: Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay

Study Design

Study Type:

Observational

Actual Enrollment :

500 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Comparison of Vitamin D Status and Vitamin D Receptor Polymorphisms in Patients With High Myopia and Primary Open-angle Glaucoma

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
primary open-angle glaucoma patients Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay	Other: Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay Other Names: Vitamin D receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment length polymorphism technique
high myopia patients Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay	Other: Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay Other Names: Vitamin D receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment length polymorphism technique
age-matched people Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay	Other: Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay Other Names: Vitamin D receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment length polymorphism technique

Arm

Intervention/Treatment

primary open-angle glaucoma patients

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

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

Other Names:

Vitamin D receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment length polymorphism technique

high myopia patients

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

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

Other Names:

Vitamin D receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment length polymorphism technique

age-matched people

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

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

Other Names:

Vitamin D receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment length polymorphism technique

Outcome Measures

Primary Outcome Measures

Serum levels of 1a, 25-Dihydroxyvitamin D3 [1 day visit]

Secondary Outcome Measures

gene polymorphisms of vitamin D receptor [1 day visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.