Polarization Sensitive Optical Coherence Tomography

Completed

• Conditions: Myopia
• Interventions: Device: Polarization sensitive optical coherence tomography (PS-OCT)

• Registration Number: NCT05809674
• Lead Sponsor: Singapore Eye Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-10
• Study First Submitted: 2023-02-12
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-10
• Last Update Submitted: 2023-04-10
• Study First Posted: 2023-04-12
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children Cohort	Polarization sensitive optical coherence tomography (PS-OCT)	* 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
Adult Cohort	Polarization sensitive optical coherence tomography (PS-OCT)	* 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

Primary Outcome Measures

Name	Time	Method
Primary Aim	1.5 years	High reproducibility in myopia cases as shown in PS-OCT derived sclera anisotropy patterns

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Singapore National Eye Centre; 🇸🇬 Singapore, Singapore