Polarization Sensitive Optical Coherence Tomography

NCT05809674 | Completed DMC

• 1 other identifier: R1819/61/2021
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Primary Aim

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

  1.5 years

Secondary Outcomes (1)

• Secondary Aim

  1.5 years

Other Outcomes (1)

• Tertiary Aim

  1.5 years

Study Arms (2)

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

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.

Adult Cohort; Children Cohort

Eligibility Criteria

• Age: 10 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult and children cohorts

You may qualify if:

• (Adult Cohort)
• Aged 21 and above
• Ability to provide informed consent
• 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
• subjects with pathological myopia (up to -12 dioptres) or staphyloma
• (Children Cohort)
• Aged 10 to 18
• subjects with low to moderate myopia (-0.75 to -6 dioptres)
• subjects with high myopia (more than -6 dioptres)
• Ability of legal representative and subject to provide informed consent

You may not qualify if:

• (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)

Sponsors & Collaborators

• Singapore Eye Research Institute: lead

Study Sites (1)

Singapore National Eye Centre

Singapore, 168753, Singapore

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: April 12, 2023
• Study Start: March 10, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

SG (1)