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NCT05576285: RISC

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

Status unknown Last updated 9 February 2023
What this trial tests

trial testing ophthalmoscopy and fundus photography through dilated pupills in Retinal Hemorrhage, Bilateral in 1,500 participants. Status unknown.

Timeline
8 February 2023
Primary endpoint
8 February 2026
8 February 2026

Quick facts

Lead sponsorRegion Stockholm
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment1,500
Start date8 February 2023
Primary completion8 February 2026
Estimated completion8 February 2026
Sites1 location across Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Region Stockholm — full company profile →

Who can join

Adults 4 Weeks to 14, any sex, with Retinal Hemorrhage, Bilateral or Retinal Hemorrhage, Left Eye. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Region Stockholm trials

Trials by the same sponsor.

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Data sources for this page

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