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Retinal Imaging Study of Children That Might be at Risk of Having Retinal Hemorrhages

NCT05576285 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2023-02-09

No results posted yet for this study

Summary

This is a clinical trial in which we will learn about the retinal findings in three clinical groups of children, who might be at risk of having retinal hemorrhages (RH). The aim of the study is to explore the occurrence of moderate to severe retinal hemorrhages in critically ill children, children with intracranial hemorrhages, hydrocephalus or signs of elevated intracranial pressure and in children with benign enlargement of subarachnoid spaces (BESS).

1. Are RHs associated with BESS?
2. What is the prevalence, distribution and extent of RHs in critically ill children?
3. What is the prevalence, distribution and extent of RHs in children with traumatic brain injury?
4. Does the prevalence, distribution and extent of RHs differ in children with witnessed traumatic brain injury from children with traumatic brain injury of unknown origin?
5. To what extent do the causes of RHs affect visual acuity, initially and during recovery? A retinal ophthalmoscopy through dilated pupils will be conducted and a fundus photograph will be taken by a handheld, non-touch camera.

Conditions

  • Retinal Hemorrhage, Bilateral
  • Retinal Hemorrhage, Left Eye
  • Retinal Hemorrhage, Right Eye

Interventions

DIAGNOSTIC_TEST

ophthalmoscopy and fundus photography through dilated pupills

ophthalmoscopy and fundus photography through dilated pupills

Sponsors & Collaborators

  • Region Stockholm

    lead OTHER_GOV

Principal Investigators

  • Kerstin M Hellgren, MD, PhD · Region Stockholm

Eligibility

Min Age
4 Weeks
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-08
Primary Completion
2026-02-08
Completion
2026-02-08

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05576285 on ClinicalTrials.gov