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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05576285
Acronym
RISC
Enrollment
1500
Registered
2022-10-12
Start date
2023-02-08
Completion date
2026-02-08
Last updated
2023-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

retinal hemorrhage

Brief 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.

Detailed description

The prospective study will take place at university hospitals in three Swedish regions, Stockholm, Skåne and Västra Götaland. The data collection from the three regions will proceed in parallel over a three-year period. An estimated number of children will be 400-500 per year. The study children will be consecutively referred to the pediatric ophthalmology units, where the ophthalmological examinations will take place. Bedside examinations will be performed when indicated at the pediatric intensive care units. Retinal fundus examination will be performed according to clinical standards following administration of pupil dilating eye drops in each eye. Visual function will be evaluated if ophthalmic abnormalities are detected. Prospective observational study Group 1: All infants ≤ 18 months of age, who undergo neuroradiological examinations of the brain on the indication increased head circumference. Group 2: All critically ill children \< 15 years of age, cared for at the hospitals, with neurological symptoms, that require neuroradiological examination of the brain. Group 3: All children ≤ 2 years of age, who undergo emergency neuroradiological examinations of the head at the hospitals.

Interventions

DIAGNOSTIC_TESTophthalmoscopy and fundus photography through dilated pupills

ophthalmoscopy and fundus photography through dilated pupills

Sponsors

Region Stockholm
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Weeks to 14 Years
Healthy volunteers
Yes

Inclusion criteria

* Infants ≤ 18 months of age, who undergo neuroradiological examinations of the brain on the indication increased head circumference * Children \< 15 years of age, cared for at the ICU, with neurological symptoms, that require neuroradiological examination of the brain * Children \< 5 years of age, who undergo emergency neuroradiological examinations of the head at the hospitals

Exclusion criteria

\- Infants with intraventricular hemorrhages due to prematurity, in the absence of increased head circumference

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with retinal hemorrhages20 minutesOphthalmoloscopy findings registered in protocol and fundus photographs
Number and distribution of retinal hemorrhages in eyes20 minutesOphthalmoloscopy findings registered in protocol and fundus photographs

Secondary

MeasureTime frameDescription
Visual function10 minutesFollowing and fixating LH face
Eye movements10 minutesFollowing and fixating LH face

Countries

Sweden

Contacts

Primary ContactHannamaria Öhnell, MD, PhD
hanna_maria.ohnell@med.lu.se+4640-332781
Backup ContactGunilla Magnusson, MD, PhD
gunilla.magnusson@vgregion.se+4631- 343 32 56

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026