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Polarization Sensitive Optical Coherence Tomography

Sponsor
Singapore Eye Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT05809674
Collaborator
(none)
178
Enrollment
1
Location
12.7
Actual Duration (Months)
14
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Polarization sensitive optical coherence tomography (PS-OCT)

Study Design

Study Type:
Observational
Actual Enrollment :
178 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Polarization Sensitive Optical Coherence Tomography - Phase II: A Pilot Study
Actual Study Start Date :
Mar 10, 2022
Actual Primary Completion Date :
Mar 31, 2023
Actual Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Primary Aim [1.5 years]

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

Secondary Outcome Measures

  1. Secondary Aim [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 Outcome Measures

  1. Tertiary Aim [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Singapore National Eye Centre Singapore Singapore 168753

Sponsors and Collaborators

  • Singapore Eye Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Singapore Eye Research Institute
ClinicalTrials.gov Identifier:
NCT05809674
Other Study ID Numbers:
  • R1819/61/2021
First Posted:
Apr 12, 2023
Last Update Posted:
Apr 12, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myopia
Hypersensitivity

Study Results

No Results Posted as of Apr 12, 2023