MyopiaNCT05809674
Polarization Sensitive Optical Coherence Tomography
An observational study of Myopia, run by Singapore Eye Research Institute at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 10 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Polarization sensitive optical coherence tomography (PS-OCT)
- Type of treatment
- Medical device
- How many people
- 178 participants
- Where
- 1 siteSingapore
- Study dates
- 10 Mar 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult and children cohorts
Who may be able to join
- (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)
Show all 10Show fewer
- 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
Who cannot join
- (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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Myopia
- Being tested
- Polarization sensitive optical coherence tomography (PS-OCT)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Polarization sensitive optical coherence tomography (PS-OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Aim
High reproducibility in myopia cases as shown in PS-OCT derived sclera anisotropy patterns
Measured: 1.5 years
Secondary outcomes (1)
Secondary Aim
Changes in scleral anisotropy in adults with different degrees of myopia (up to -12 dioptres), as associated with the presence of staphyloma
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start10 Mar 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Eye Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809674
- Sponsor's protocol ID
- R1819/61/2021
- Status last verified
- Apr 2023
- First submitted
- 12 Feb 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polarization Sensitive Optical Coherence Tomography - Phase II: A Pilot Study
- ClinicalTrials.gov ID
- NCT05809674
- Acronym / sponsor ID
- R1819/61/2021
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Singapore Eye Research InstituteUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult Cohort | – | Device: 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 |
| Children Cohort | – | Device: 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 |
Who may qualify
- Ages
- 10 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and children cohorts
Key inclusion criteria (10 listed)
- (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
Key exclusion criteria (4 listed)
- (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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Adult Cohort, Children Cohort |
Primary outcome
Primary Aim
Time frame: 1.5 years
High reproducibility in myopia cases as shown in PS-OCT derived sclera anisotropy patterns
1 secondary outcome
Secondary Aim
Time frame: 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Singapore Eye Research Institute at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Aim (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.