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Polarization Sensitive Optical Coherence Tomography

Polarization Sensitive Optical Coherence Tomography - Phase II: A Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05809674
Enrollment
178
Registered
2023-04-12
Start date
2022-03-10
Completion date
2023-03-31
Last updated
2023-04-12

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

Conditions

Myopia

Brief summary

The purpose of the study is to use the polarization sensitive optical coherence tomography (PS-OCT) developed by Singapore Eye Research Institute, to evaluate the potential OCT scleral biomarkers capable of predicting risk of myopia progression.

Interventions

DEVICEPolarization sensitive optical coherence tomography (PS-OCT)

The PS-OCT is a prototype, also known as an early version of a medical device, specially developed by the Ocular Imaging Research Group, Singapore Eye Research Institute, for prediction of myopia progression. It has not been approved for use in any other country. There is currently no method to identify who is at risk of myopia progression. The PS-OCT device will provide the capabilities of OCT scleral biomarkers, which may have the potential to identify individuals at high risk for myopia.

Sponsors

Singapore Eye Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
10 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

(Adult Cohort) * Aged 21 and above * Ability to provide informed consent * 42 normal controls: No diabetes and free from clinically relevant eye disease that interferes with the aim of the study i.e. glaucoma, diabetic retinopathy, age-related macular degeneration, uveitis, or vascular occlusive diseases * 76 subjects with pathological myopia (up to -12 dioptres) or staphyloma (Children Cohort) * Aged 10 to 18 * 23 subjects with low to moderate myopia (-0.75 to -6 dioptres) * 23 subjects with high myopia (more than -6 dioptres) * Ability of legal representative and subject to provide informed consent

Exclusion criteria

(Adult Cohort) * Unable to give consent * Subjects with visual acuity worse than 6/12 * Diagnosis of clinically relevant eye disease that interferes with the aim of the study (e.g. diabetic retinopathy, hereditary macular disease, glaucoma, uveitis, or vascular occlusive diseases) or conditions that may potentially result in poor quality imaging scans (severe cataract, corneal haze/opacity)

Design outcomes

Primary

MeasureTime frameDescription
Primary Aim1.5 yearsHigh reproducibility in myopia cases as shown in PS-OCT derived sclera anisotropy patterns

Secondary

MeasureTime frameDescription
Secondary Aim1.5 yearsChanges in scleral anisotropy in adults with different degrees of myopia (up to -12 dioptres), as associated with the presence of staphyloma

Other

MeasureTime frameDescription
Tertiary Aim1.5 yearsAnisotropy correlation with refraction and axial length in children with low (-0.75 to -6 dioptres) and high (more than -6 dioptres) myopia, as measured by PS-OCT

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026