ACTRN12624000887572
Not yet recruiting
未知
Investigation of Optical Coherence Tomography Angiography (OCTA) as a non-invasive technique to detect early retinal microvascular dysfunction in children with Diabetes Mellitus
ions Eye Institute0 sites401 target enrollmentJuly 22, 2024
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- diabetes mellitus
- Sponsor
- ions Eye Institute
- Enrollment
- 401
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diabetic Participants:
- •Children aged 10\-18 diagnosed with diabetes Type 1 or 2
- •Participant or parent/guardian willing and able to provide informed consent
- •Participant in the Western Australian Children's Diabetes Database
- •grading of no retinopathy per ETDRS classification
- •normal urine and serum kidney biomarkers
- •Healthy Participants:
- •Aged 10\-18
- •Participant or parent/guardian willing and able to provide informed consent
- •Normal visual acuity, retinal images and no history of ocular disease
Exclusion Criteria
- •For both healthy and diabetic participants:
- •1\.Abnormal results from serum or urine kidney biomarker samples as determined by the study doctor
- •2\.Presence or history of any clinically significant disease or condition, or taking medications that in the opinion of the investigator may affect participant safety or affect the outcome of the investigation
- •3\.Participants, who in the opinion of the investigator are not likely to complete the study for whatever reason
- •4\.For healthy participants only \- abnormal Visual Acuity or retinal colour photography images, history of ocular disease (including refractive error greater than \-2D dioptres of myopia or \+3 dioptres of hyperopia); Abnormal urine kidney biomarkers or HbA1c.
Outcomes
Primary Outcomes
Not specified
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