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临床试验/NCT06649513
NCT06649513尚未招募不适用

Long-term Ophthalmic Outcomes in Ex-premature Infants

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
210
试验地点
1
主要终点
Visual acuity

研究概览

简要总结

There is limited knowledge on ophthalmological outcomes in the adult population that was born prematurely. This study aims to evaluate the ophthalmic outcomes of ex-premature infants that have reached adolescence or adulthood.

详细描述

Every year, around 18.000 children in the Netherlands are born prematurely, which means that they were born before 37 weeks gestational age. The WHO defines three different categories of prematurity: moderate to late preterm (32-37 weeks), very preterm (<32-28 weeks), and extremely preterm (<28 weeks). Preterm birth is associated with numerous health problems, which can have both short-term and long-term consequences on the development of the child. A relatively rare complication of (very or extreme) preterm birth is lifelong visual impairment or blindness due to retinal detachment as a result of prematurity retinopathy (ROP). ROP is a vasoproliferative condition that affects the vessels in the retina. An inventory study shows that 305 children were diagnosed with ROP in the Netherlands in 2017. The majority of these children experienced spontaneous regression of the condition, but 13% of cases required treatment to prevent retinal detachment. In the long-term, ROP predisposes for ocular conditions such as visual field abnormalities, refractive error, strabismus, amblyopia, glaucoma and retinal detachment. However, research also indicates that prematurity, regardless of ROP diagnosis, can also be associated with adverse ophthalmological outcomes such as refractive error, strabismus, amblyopia and cerebral visual impairment (CVI). Although there are various publications on the ophthalmological outcomes of ROP and prematurity at school-age, less is known about these outcomes in the adult population. This study aims to investigate the anatomy and functionality of the eye in ex-premature infants who were born between 1991 and 2006. In addition, the differences in outcomes between ex-premature infants with and without ROP, and the differences in outcomes between treated and spontaneously regressed ROP, will be studied.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects eligible for ROP screening, and admitted to Erasmus MC between 1991 and 2007.

排除标准

  • Subjects born after 2008,
  • Subject has passed away before the start of the study
  • Subject resides outside of the Netherlands
  • Subject has a physical or mental disability that makes it impossible to participate in a routine eye exam, or has a disability that classifies the subject as an incapacitated adult.

结局指标

主要结局

Visual acuity

时间窗: The primary outcome measure will be assessed at one single visit to Erasmus MC. This one-off measurement will not be repeated, nor is there a specific time-frame for this measurement.

Measured with ETDRS chart. Expressed in Logarithm of the Minimum Angle of Resolution (LogMAR)

次要结局

  • Biometric, refractive, fundus and Optical coherence tomography (OCT) data.(The secondary outcome measures will be assessed at one single visit to Erasmus MC. These one-off measurements will not be repeated, nor are there a specific time-frames for these measurements.)

研究者

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

Angela M. Arends-Tjiam, MD PhD

Pediatric Ophthalmologist

Erasmus Medical Center

研究点 (1)

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