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CompletedNCT05809674Updated Apr 12, 2023

Polarization Sensitive Optical Coherence Tomography

An observational study in Myopia, sponsored by Singapore Eye Research Institute. Completed at 1 site in Singapore. Open to participants aged 10 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-12.

Sponsored by Singapore Eye Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
178
Ages
10 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Myopia
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 178 is above the median of 150 across 173 observational studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Singapore Eye Research Institute is the lead sponsor of 26 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adult and children cohorts

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

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)
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
178 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Device: Polarization sensitive optical coherence tomography (PS-OCT)

  • 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

    Device: Polarization sensitive optical coherence tomography (PS-OCT)

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.

06

What researchers measure

Primary outcomes

  1. Primary Aim

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

    Time frame: 1.5 years

Secondary outcomes

  1. 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

Other outcomes

  1. Tertiary Aim

    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

    Time frame: 1.5 years

07

Study locations

1 site
  • Singapore National Eye Centre
    Singapore, 168753, Singapore
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05809674
Lead sponsor
Singapore Eye Research Institute
Responsible party
Sponsor
First posted
Apr 12, 2023
Start date
Mar 10, 2022
Primary completion
Mar 31, 2023
Completion
Mar 31, 2023
Last update
Apr 12, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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