Evaluation of Retinal Structure in Pediatric Subjects With Vitamin D Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The central retinal artery and vein calibers
研究概览
简要总结
Retinal tissue parameters of pediatric patients with vitamin D deficiency will be evaluated in this prospective case-control study. The patients will be divided into 2 groups according to the vitamin D level. Retinal vessel diameters, retinal nerve fiber evaluation, choroidal thickness will be evaluated. Choroidal thinning decrease in retinal artery diameter and increase in retinal vein diameter will be detected in the vitamin D deficiency group.
详细描述
The study of the relationship between vitamin D status and retinal diseases is a new concept, and there is a large gap in research focusing on the pediatric population in the literature. The importance of vitamin D in retinal maturation and its role in the development of retinal diseases at a young age is being investigated. In this sense, as far as known, it is the first study investigating retinal structure parameters in pediatric patients with vitamin D deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Patients will be examined without knowing their vitamin D level. The OCT evaluations will be performed by a highly trained ophthalmic technician, and the compatibility of the results will be confirmed by two experienced retinal specialists.
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age <18 years old
- •serum vitamin D [(25(OH) D), calcitriol] level <20 ngr/mL in previous two weeks
- •visual acuity >20/20
- •manifest refraction spherical equivalent <3D
- •normal biomicroscopic and fundus examination.
排除标准
- •history of any chronic ocular diseases, except for refractive error (e.g., uveitis, glaucoma, retinopathy of prematurity)
- •history of ocular surgery (e.g., cataract, strabismus, open globe injury, laser photocoagulation)
- •having an ocular abnormality (e.g., persistent fetal vasculature, optic disc hypoplasia, fovea plana)
- •history of systemic diseases that have the potential to affect ocular tissues (e.g., diabetes mellitus, Graves' disease, albinism, Down syndrome, Fabry diseases, Wilson syndrome)
- •history of any systemic diseases that can affect the serum vitamin D level (e.g., parathormone or calcium metabolism disorders)
- •already receiving vitamin D treatment.
结局指标
主要结局
The central retinal artery and vein calibers
时间窗: up to 3 months
The central retinal artery and vein calibers will be analyzed with the Interactive Vessel Analyzer
choroidal thickness
时间窗: up to 3 months
subfoveal, and subfoveal 1500-µm- and 3000-µm-diameter distance nasal and temporal areas
retinal nerve fiber layer
时间窗: up to 3 months
Retinal nerve fiber layer will be detected by optical coherence tomography
次要结局
- blood vitamin D levels(up to 3 months)
研究者
Emre Aydemir
Principal Investigator
Adiyaman University