An observational study in Retinopathy of Prematurity and Diabetic Retinopathy, sponsored by Insel Gruppe AG, University Hospital Bern. Withdrawn. Open to participants aged 6 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-17.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
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Comparison of OCTA to conventional imaging modalities for the diagnosis of eye diseases in children
Optical coherence tomography angiography (OCTA) is a new non-invasive imaging technique that employs motion contrast imaging to high-resolution volumetric blood flow information. OCTA compares the decorrelation signal between sequential OCT b-scans taken at precisely the same cross-section in order to construct a map of blood flow. At present, level 1 evidence of the technology's clinical applications doesn't exist. The investigators plan to compare OCTA as an imaging modality to conventional imaging modalities used in clinical routine.
169 studies on the registry are indexed under Retinopathy of Prematurity; 27 are open to participants now.
Browse Retinopathy of Prematurity studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 179 are open to participants now.
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Participants with a history of clinically diagnosed retinal diseases and healthy individuals undergoing ophthalmic Imaging in Routine clinical practice will be included
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children without eye disease
Device: OCT-A
Previously preterm children with a history of ROP
Device: OCT-A
Children with diabetes
Device: OCT-A
optical coherence tomography angiography Imaging with optical coherence tomography angiography
Evaluation of the sensitivity and specificity of OCTA
The primary objective of this observational study is to evaluate the sensitivity and specificity to diagnose vascular abnormalities with OCTA compared to conventional imaging methods. The main parameter that will be assessed is area of nonperfusion of the retina. The incidence (binary) of nonperfusion areas will be assessed in OCTA and compared to conventional imaging methods such as fluorescein angiography.
Time frame: 2 years
No study locations are listed for this record.
Start is estimated for Jan 2018.
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This study is withdrawn, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern →