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Completed

NCT Number: NCT05809674

Polarization Sensitive Optical Coherence Tomography

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

10 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Singapore National Eye Centre

Singapore, 168753

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Primary Aim

    Time frame: 1.5 years

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

Secondary outcomes

  1. Secondary Aim

    Time frame: 1.5 years

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

Other outcomes

  1. Tertiary Aim

    Time frame: 1.5 years

    Anisotropy 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

Sponsors and collaborators

Lead sponsor

Singapore Eye Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2023
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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