HealthyNCT03783858
Image Collection of Normal Eyes for Development of an EU RDB
A study testing P200TE in people with Healthy, run by Optos, PLC at 5 sites in United Kingdom.
Trial summary
This study is designed to collect in-tissue OCT scans on the Optos P200TE on normal healthy eyes to develop a EU reference database Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- P200TE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 30 May 2019to 20 Apr 2020
- Phase
- Interventional
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject 22 years of age or older on the date of informed consent
- Subject able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- Subject presenting at the site with normal eyes* (Cataracts and LASIK and PRK are allowed)
- BCVA 20/40 or better (each eye)
- Subject is able to comply with the study procedures in the view of the investigator *Normal eyes are defined as eyes judged normal for the subjects age as determined by the PI or sub-investigator
Who cannot join
- 1.1. Subject unable to tolerate ophthalmic imaging 2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images 3. History of leukemia, dementia or multiple sclerosis
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Simon Browning Optometrist
Bedford, England, MK40 2SR
Queens University
Belfast, Northern Ireland, BT7 1NN
Cameron Optometry
Edinburgh, Scotland, EH3 6SW
Barnard Levit Optometrists
London, England, NW11 7EL
London Vision Clinic
London, England, W1G 7LA
About this study
Official title: Image Collection of Normal Eyes on the Optos P200TE for Development of an EU Reference Database
This study is designed to collect in-tissue OCT scans on the Optos P200TE on normal healthy eyes to develop a EU reference database
- Conditions
- Healthy
- Being tested
- P200TE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P200TEDevice
OCT images
| Study group | Role | What they receive |
|---|---|---|
| Single | Other | Not described Receives: Device: P200TE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal thickness
In general, descriptive statistics (n, mean, standard deviation, median, minimum and maximum) and 95% confidence interval for the mean will be used to summarize each scan parameters.
The 1st, 5th, 95th and 99th percentile results will be tabulated. All percentile results will be incorporated in the device software.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start30 May 2019
- Primary completion8 Oct 2019
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optos, PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tunde Peto, PhD, Principal investigator, Queens University Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783858
- Sponsor's protocol ID
- OPT1030
- Status last verified
- Jun 2020
- First submitted
- 19 Dec 2018
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Collection of Normal Eyes on the Optos P200TE for Development of an EU Reference Database
- ClinicalTrials.gov ID
- NCT03783858
- Acronym / sponsor ID
- OPT1030
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Optos, PLCIndustry (pharma, biotech, devices)
- Study start
- 30 May 2019 (actual)
- Primary completion
- 8 Oct 2019 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 21 Dec 2018 (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.
This study is designed to collect in-tissue OCT scans on the Optos P200TE on normal healthy eyes to develop a EU reference database
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Other | Device: P200TE |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject 22 years of age or older on the date of informed consent
- Subject able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- Subject presenting at the site with normal eyes* (Cataracts and LASIK and PRK are allowed)
- BCVA 20/40 or better (each eye)
- Subject is able to comply with the study procedures in the view of the investigator *Normal eyes are defined as eyes judged normal for the subjects age as determined by the PI or sub-investigator
Key exclusion criteria (1 listed)
- 1.1. Subject unable to tolerate ophthalmic imaging 2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images 3. History of leukemia, dementia or multiple sclerosis
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 |
|---|---|---|
| P200TEOCT images | Device | Single |
Primary outcome
Retinal thickness
Time frame: 1 day
In general, descriptive statistics (n, mean, standard deviation, median, minimum and maximum) and 95% confidence interval for the mean will be used to summarize each scan parameters. The 1st, 5th, 95th and 99th percentile results will be tabulated. All percentile results will be incorporated in the device software.
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 9 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Tunde Peto, PhD principal investigator
Queens University Belfast
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P200TE in people with Healthy, run by Optos, PLC at 5 sites in United Kingdom.
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 5 inclusion and 1 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. 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?
Retinal thickness (time frame: 1 day). 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 9 Jun 2020.