跳至主要内容
临床试验/NCT06044181
NCT06044181招募中不适用

Long Term Management of Peripheral Avascular Retina in Retinopathy of Prematurity Evaluated by Fundus Fluorescein Angiography.

Assiut University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
2
主要终点
Number of eyes showing peripheral retinal active leakage.

研究概览

简要总结

Retinopathy of prematurity (ROP) is a widely known retinal vascular disorder in preterm infants and a leading cause of visual disability or blindness in children. Advances in antenatal care have resulted in an increase in the survival rate of infants with extremely low birth weight (BW). Approximately 90% of infants who develop ROP do so by a postmenstrual age of 46.3 weeks. In certain patients with or without treatment, the retina may fail to fully vascularize or may develop vascular abnormalities, thus demonstrating persistent avascular retina (PAR) or anomalous vessel findings at the periphery. Because of the advent of technologies such as ultrawide-field fluorescein angiography (UWFFA) persistent vascular abnormalities can be detected more readily and investigated.

详细描述

The natural history of peripheral nonperfusion and vascular abnormalities, which persist beyond the acute phase of ROP, remains poorly understood. Although patients with a history of type I ROP (treatment requiring ROP) are more likely to exhibit abnormal foveal development and poor vision, a discrepancy still exists between the structural and functional findings of vascular abnormalities in the long term. For instance, circumferential atypical vessels are detected in patients with spontaneously regressed ROP and favorable vision. Additionally, persistent retinal vascular abnormalities may not necessarily predict adverse functional outcomes. The significance of such vessel anomalies and whether they persist or not remain uncertain. The physiologic avascular retina of children of age < 13 years usually extends ≤ 1.5 DD temporally or ≤ 1.0 DD nasally from the ora serrata. Therefore, the PAR (peripheral avascular retina) is defined as the nonperfusion area with measurements ≥ 2.0 DD, which is 3 standard deviations more than the normal value. Infants with persistent avascular retina have unknown long-term structural and functional risks, and theoretically could develop disease requiring treatment, including retinal breaks or tractional bands. Prolonged retinal traction by remnant shunt or extra-retinal fibrovascular proliferation between a stable prenatally vascularized retina in the posterior pole and an unstable postnatally vascularized retina may lead to the development of retinal holes characteristically located in the fragile, anterior undifferentiated avascular retina. Treatment options may vary from observation to retinal laser photocoagulation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Months 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with persistent peripheral avascular retina attending follow up till the age of 18 months in the core study whether;
  • regressed ROP: children with regressed ROP who had not received any treatment.
  • IVI treatment ROP: children with a history of threshold ROP treated with IVI of anti-VEGF agents.

排除标准

  • Eyes with previous laser therapy.
  • Eyes with any other pathology, other than ROP.
  • Eyes with stage 4 or 5 ROP.
  • Patients with hypersensitivity to iodinated contrast media, liver and renal insufficiency, history of asthma.
  • Patients who will show hypersensitivity reaction to fluorescein angiography will be excluded from the thesis.
  • Patients unfit for general anesthesia.

结局指标

主要结局

Number of eyes showing peripheral retinal active leakage.

时间窗: 18 months

Management of active leakage by laser ablation.

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

Alyaa mohamed yousef ahmed elkabsh

principle investigator

Assiut University

研究点 (2)

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