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临床试验/NCT06452524
NCT06452524已完成不适用

The Precondition of Retinopathy of Prematurity on Visual Acuity, Refraction, Biometric Values, Retinal and Choroidal Thickness in School-Aged Children

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 211 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
211
试验地点
1
主要终点
Anterior Chamber Depth

研究概览

简要总结

Ophthalmological differences in school-aged children with and without a history of retinopathy of prematurity

详细描述

Aims: To compare functional (visual acuity and refractive error) and anatomical (biometric values, foveal and choroidal thickness) ophthalmological differences in school-aged children with and without a history of retinopathy of prematurity (ROP).

Settings and Design: Prospective Cross-Sectional Study

Methods and Material: The study was conducted prospectively in the ophthalmology department of Ankara Bilkent City Hospital. Subjects were divided into three groups: 29 children who were treated with laser photocoagulation (ROP-TxGroup), 26 children who developed ROP and did not need treatment (ROP-non-TxGroup), and 25 children who did not develop ROP (Premature Group). The 27 healthy children with a history of full-term born (Control Group), who were in a similar age group for 'control eye examination', were accepted as the control group. A total of 107 patients and 211 eyes were included in the study. Non-cycloplegic and cycloplegic refraction, best corrected visual acuity (BCVA), keratometry, axial length (AL) and anterior chamber depth (ACD), optical coherence tomography (OCT) macular and OCT subfoveal choroidal measurements were performed in all cases.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
5 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with a history of ROP

排除标准

  • Stage 4-5 ROP, Presence of media opacities (such as cataract) Ocular trauma or ocular surgery Hydrocephalus or grade 3 and above intracerebral hemorrhage, Uncooperative children

结局指标

主要结局

Anterior Chamber Depth

时间窗: 4mounth after the procedure

Milimeter

K1 Flat and K2 Steep

时间窗: 4mounth after the procedure

Dioptre

Axial Length

时间窗: 4mounth after the procedure

Milimeter

Astigmatism

时间窗: 4mounth after the procedure

Dioptre

Best Corrected Visual Acuity

时间窗: 4mounth after the procedure

logMAR

Spherical Equivalents

时间窗: 4mounth after the procedure

Dioptre

Macular and Choroidal Thickness

时间窗: 4mounth after the procedure

Micrometer

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Kutay KILINÇ

Principal Investigator

Ankara City Hospital Bilkent

研究点 (1)

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