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Study of the retinal structure in patients with Autism Spectrum Disorder

Structural retinal evaluation with optical coherence tomography in patients with Autism Spectrum Disorder

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-72wsmt7
Enrollment
Unknown
Registered
2025-10-03
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Autism Spectrum Disorder

Interventions

This is a cross-sectional observational study, therefore there is no randomization or masking of participants or evaluators .The study consists of two groups: Group 1 will be composed of 20 participan

Sponsors

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Collaborator

Eligibility

Age
7 Years to 20 Years

Inclusion criteria

Inclusion criteria: Diagnosis of Autism Spectrum Disorder according to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders criteria (for the study group) or absence of Autism Spectrum Disorder criteria (for the neurotypical control group); Age between 7 and 20 years; Refractive error of less than 6 spherical diopters and less than 3 cylindrical diopters in absolute values; Best-corrected visual acuity of 0.5 decimal or better; Absence of a history or signs of other ocular diseases; Absence of other general health conditions that could affect Optical Coherence Tomography measurements; Ability to collaborate to obtain high-quality and reliable Optical Coherence Tomography exams

Exclusion criteria

Exclusion criteria: Non-verbal patients with Autism Spectrum Disorder; Patients with retinal alterations identified on fundoscopy that could interfere with the results of the Optical Coherence Tomography exam

Design outcomes

Primary

MeasureTime frame
It is expected to find a statistically significant difference in the mean thickness of the macular and peripapillary retinal layers, verified by statistical analysis (Student's t-test or Mann-Whitney test) of the measurements obtained by Optical Coherence Tomography, from the finding of a p-value < 0.05 in the comparison between the group with autism spectrum disorder and the neurotypical control group

Secondary

MeasureTime frame
It is expected to find a statistically significant correlation between retinal thickness measurements and clinical variables of autism spectrum disorder, verified by statistical analysis (Pearson or Spearman correlation) of the data, based on the identification of a significant correlation coefficient (r) with a p-value < 0.05

Countries

Brazil

Contacts

Public ContactKarin Takatsu

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

karin.chiaradia@yahoo.com.br+55(11)2661-0000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)