Detecting early eye changes in diabetic children using Optical Coherence Tomography Angiography (OCTA)

Not Applicable

Conditions: diabetes mellitus
diabetic retinopathy
Eye - Diseases / disorders of the eye
Metabolic and Endocrine - Diabetes

Registration Number: ACTRN12624000887572

Lead Sponsor: ions Eye Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 401

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
normal urine and serum kidney biomarkers and Hb1Ac

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Coefficient of Variation (CV) measure between non-DM children and DM children without diabetic retinopathy (DR),<br><br>CV measure is Coefficient of Variation measure and is calculated as described in Description of intervention(s) / exposure with repeated OCTA scans. <br><br>[ 2 year follow-up and 4 year follow-up post enrolment ];Severity of DR determined by CV measure derived from OCTA[ 2 year follow-up and 4 year follow-up post enrolment ];Severity of diabetic nephropathy determined by CV measure derived from OCTA[ 2 year follow-up and 4 year follow-up post enrolment]

Secondary Outcome Measures