Polarization Sensitive Optical Coherence Tomography

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

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 Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Polarization sensitive optical coherence tomography (PS-OCT)

• Study Type: Observational
• Enrollment (Actual): 178

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 168753
    • Singapore National Eye Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult and children cohorts

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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	Device: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1.5 years

Collaborators and Investigators

• Sponsor: Singapore Eye Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: February 12, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Eye Diseases; Refractive Errors; Hypersensitivity; Myopia
• Other Study ID Numbers: R1819/61/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No