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Evaluation of subfoveal choroidal thickness and retinal microvasculature using enhanced depth imaging-optical coherence tomography (EDI-OCT) and OCT angiography (OCTA) in paediatric and adolescent diabetes mellitus

Evaluation of subfoveal choroidal thickness and retinal microvasculature using enhanced depth imaging-optical coherence tomography (EDI-OCT) and OCT angiography (OCTA) in paediatric and adolescent diabetes mellitus

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250206013
Enrollment
158
Registered
2025-02-06
Start date
2023-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Evaluation of subfoveal choroidal thickness and retinal microvasculature using enhanced depth imaging-optical coherence tomography (EDI-OCT) and OCT angiography (OCTA) in paediatric and adolescent diabetes mellitus enhanced depth imaging-optical coherence tomography (EDI-OCT),OCT angiography OCTA),

Interventions

The patient will visit the ophthalmology clinic for an eye assessment, which includes visual acuity testing, auto refraction, non contact tonometry, fundus photography using the Optos machine, EDI OCT
s cooperation. All the mentioned tests are non invasive and do not involve any radiation. There have been no reports of long term side effects associated with these tests. Patients will be provided w
s cooperation. All the mentioned tests are non invasive and do not involve any radiation. There have been no reports of long term side effects associated with these tests. Healthy volunteers will be
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
diabetes mellitus group,Control group

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 8 to 18 years with a diagnosis of diabetes mellitus (type 1 or type 2) for more than 1 year. 2. Healthy age-matched controls will be included.

Exclusion criteria

Exclusion criteria: 1. History of prematurity 2. Poor fundus view due to any ocular disease such as ocular inflammatory disease, corneal opacities, cataract and vitreous haze 3. Pre-existing retinal pathologies such as chorioretinal scar, myelinated nerve fibers, and retinal drusen that may change the retinal thickness 4. Refractive error with spherical equivalence of more than -6D 5. History of ocular injury such as penetrating injury, traumatic optic neuropathy and ocular uveitis 6. History of any ocular surgeries 7. Systemic diseases other than diabetes 8. Patient with intraocular pressure more than 21mmHg or diagnosed glaucoma

Design outcomes

Primary

MeasureTime frame
Vision assessment - visual acuity measurement, autorefraction, non-contact intraocular pressure test, Optos retinal imaging, EDI-OCT, and OCTA.

Secondary

MeasureTime frame
N/A N/A N/A

Countries

Thailand

Contacts

Public ContactProfessor Laongsri Atchaneeyasakul

Faculty of Medicine Siriraj Hospital, Mahidol University

atchanee@hotmail.com024198037

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026