Polarization Sensitive Optical Coherence Tomography

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05809674
• Other study ID #: R1819/61/2021
• Status: Completed
• Start date: March 10, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: Singapore Eye Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypersensitivity
• Myopia

Intervention

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.

Locations

Country	Name	City	State
Singapore	Singapore National Eye Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore Eye Research Institute

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Primary Aim	High reproducibility in myopia cases as shown in PS-OCT derived sclera anisotropy patterns	1.5 years
Secondary	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