Retinal DiseaseNCT05615896
Data Collection With the P200TE and P200TxE
A study testing Imaging Session in people with Retinal Disease, run by Optos, PLC at 1 site in United States.
Trial summary
The primary objective is to collect OCT scans on a modified P200TxE and P200TE. 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?
- Imaging Session
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2021to 17 Jun 2022
- 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 volunteers 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
- Volunteers who can follow the instructions by the clinical staff at the clinical site;
- Volunteers who agree to participate;
- Volunteers who have been diagnosed with retina pathology with intra-retinal and/or subretinal fluid present in the posterior pole region.
Who cannot join
- Volunteers unable to tolerate ophthalmic imaging;
- Volunteers 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 Texas Research Centers
Houston, Texas, 77401
About this study
Official title: Data Collection With the P200TE and P200TxE in Diseased Eyes for Clinical Developments
The primary objective is to collect OCT scans on a modified P200TxE and P200TE.
- Conditions
- Retinal Disease
- Being tested
- Imaging Session
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging SessionDevice
Various scans will be captured on both devices
| Study group | Role | What they receive |
|---|---|---|
| P200TxE Device First | Experimental | Not described Receives: Device: Imaging Session |
| P200TE Device First | Experimental | Not described Receives: Device: Imaging Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of images
The primary endpoint will be the collection of OCT scans on the P200TE and P200TxE devices. The scans will be used by R\&D for development of a de-noising algorithm as well as other possible developments.
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 posted14 Nov 2022
- Study start22 Apr 2021
- Primary completion28 Apr 2021
- Study completion17 Jun 2022
Why it stopped: The study is no longer required.
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- A
- Masking
- None (open label)
- Enrolment
- 5 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
- NCT05615896
- Sponsor's protocol ID
- OPT1037
- Status last verified
- Mar 2024
- First submitted
- 21 Jun 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection With the P200TE and P200TxE in Diseased Eyes for Clinical Developments
- ClinicalTrials.gov ID
- NCT05615896
- Acronym / sponsor ID
- OPT1037
- Conditions
- Retinal Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study is no longer required.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Optos, PLCIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 14 Nov 2022 (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 primary objective is to collect OCT scans on a modified P200TxE and P200TE.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A
| Arm | Type | Receives |
|---|---|---|
| P200TxE Device First | Experimental | Device: Imaging Session |
| P200TE Device First | Experimental | Device: Imaging Session |
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 volunteers 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
- Volunteers who can follow the instructions by the clinical staff at the clinical site;
- Volunteers who agree to participate;
- Volunteers who have been diagnosed with retina pathology with intra-retinal and/or subretinal fluid present in the posterior pole region.
Key exclusion criteria (2 listed)
- Volunteers unable to tolerate ophthalmic imaging;
- Volunteers 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 |
|---|---|---|
| Imaging SessionVarious scans will be captured on both devices | Device | P200TE Device First, P200TxE Device First |
Primary outcome
Collection of images
Time frame: 1 year
The primary endpoint will be the collection of OCT scans on the P200TE and P200TxE devices. The scans will be used by R\&D for development of a de-noising algorithm as well as other possible developments.
Results and safety
The study was stopped early (reason given: The study is no longer required.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- 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 Imaging Session 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: stopped early, as of the sponsor's last update on 12 Mar 2024. 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 was stopped early (reason given: The study is no longer required.). Results are not available in the source record.
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?
Collection of images (time frame: 1 year). 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 Mar 2024.