Polarization Sensitive Optical Coherence Tomography

Study Overview
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Brief Summary
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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.

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

Conditions
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Myopia

Intervention / Treatment
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* Device: Polarization sensitive optical coherence tomography (PS-OCT)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult Cohort<br>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 | Device: Polarization sensitive optical coherence tomography (PS-OCT)<br>* 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.<br>|
| Children Cohort<br>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 | Device: Polarization sensitive optical coherence tomography (PS-OCT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Aim | High reproducibility in myopia cases as shown in PS-OCT derived sclera anisotropy patterns | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Aim | Changes in scleral anisotropy in adults with different degrees of myopia (up to -12 dioptres), as associated with the presence of staphyloma | 1.5 years |