Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
178 participants
OBSERVATIONAL
2022-03-10
2023-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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
Polarization 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.
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
Polarization 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.
Interventions
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Polarization 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
10 Years
99 Years
ALL
Yes
Sponsors
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Singapore Eye Research Institute
OTHER
Responsible Party
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Locations
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Singapore National Eye Centre
Singapore, , Singapore
Countries
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Other Identifiers
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R1819/61/2021
Identifier Type: -
Identifier Source: org_study_id
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