Retinal DiseaseNCT04003831
Navigated OCT Imaging With the P200TxE
A study testing Device: P200TxE in people with Retinal Disease, run by Optos, PLC at 1 site in United States.
Trial summary
The P200TxE will be used to obtain peripheral OCT (optical coherence tomography) images. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Retinal Disease
- What is being tested?
- Device: P200TxE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2019to 18 Jan 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
- Subjects who can follow the instructions by the clinical staff at the clinical site,
- Subjects who agree to participate in the study;
- Subjects presenting with some form of peripheral retina pathology or retina pathology with peripheral manifestations.
Who cannot join
- Subjects unable to tolerate ophthalmic imaging;
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
Trial locations and contacts
1 site in 1 country.
United States1 site
Retina Consultants of San Diego
Poway, California, 92064
About this study
Official title: Navigated Peripheral OCT Imaging With the P200TxE
The P200TxE will be used to obtain peripheral OCT (optical coherence tomography) images.
- Conditions
- Retinal Disease
- Being tested
- Device: P200TxE
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: P200TxEDevice
The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
| Study group | Role | What they receive |
|---|---|---|
| Optical Coherence Tomographer | Other | Not described Receives: Device: Device: P200TxE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Assessment of OCT Clinical Utility
Clinical utility of the OCT scans will be assessed from the clinician questionnaire using a four point scale.
Measured: 1 year
Qualitative Assessment of OCT Scan Quality
Image quality of the OCT scans will be assessed from the clinician questionnaire using a four point scale.
Measured: 1 year
Secondary outcomes (1)
Safety Assessment from Adverse Events
Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start13 Jun 2019
- Primary completion16 Dec 2020
- Study completion18 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optos, PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003831
- Sponsor's protocol ID
- OPT1033
- Status last verified
- Mar 2021
- First submitted
- 12 Jun 2019
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigated Peripheral OCT Imaging With the P200TxE
- ClinicalTrials.gov ID
- NCT04003831
- Acronym / sponsor ID
- OPT1033
- Conditions
- Retinal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Optos, PLCIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 1 Jul 2019 (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 P200TxE will be used to obtain peripheral OCT (optical coherence tomography) images.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optical Coherence Tomographer | Other | Device: Device: P200TxE |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
- Subjects who can follow the instructions by the clinical staff at the clinical site,
- Subjects who agree to participate in the study;
- Subjects presenting with some form of peripheral retina pathology or retina pathology with peripheral manifestations.
Key exclusion criteria (2 listed)
- Subjects unable to tolerate ophthalmic imaging;
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
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 |
|---|---|---|
| Device: P200TxEThe P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device. | Device | Optical Coherence Tomographer |
Primary outcome
Qualitative Assessment of OCT Clinical Utility
Time frame: 1 year
Clinical utility of the OCT scans will be assessed from the clinician questionnaire using a four point scale.
Qualitative Assessment of OCT Scan Quality
Time frame: 1 year
Image quality of the OCT scans will be assessed from the clinician questionnaire using a four point scale.
1 secondary outcome
Safety Assessment from Adverse Events
Time frame: 1 year
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 3 Mar 2021.
- 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.
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?
A study testing Device: P200TxE in people with Retinal Disease, run by Optos, PLC at 1 site in United States.
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 4 inclusion and 2 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 3 Mar 2021. 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 United States. 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?
Qualitative Assessment of OCT Clinical Utility (time frame: 1 year). The study lists 2 primary outcomes in all. 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 3 Mar 2021; AzTrials last refreshed its copy on 3 Nov 2026.