Polarization Sensitive Optical Coherence Tomography

Singapore Eye Research Institute178 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

178

Conditions

Myopia

Interventions

Polarization sensitive optical coherence tomography (PS-OCT)DEVICE

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.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Singapore National Eye Centre

Singapore, Singapore

Outcomes

Primary Outcomes

Primary Aim

High reproducibility in myopia cases as shown in PS-OCT derived sclera anisotropy patterns

Time frame: 1.5 years

Secondary Outcomes

Secondary Aim

Changes in scleral anisotropy in adults with different degrees of myopia (up to -12 dioptres), as associated with the presence of staphyloma

Time frame: 1.5 years

Data from ClinicalTrials.gov

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