Retinal DiseaseNCT03964831
Study Comparing the P200TxE and P200DTx
A study testing P200TxE and P200DTx in people with Retinal Disease, run by Optos, PLC at 1 site in United States.
Trial summary
The study evaluates image quality between two devices. 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?
- P200TxE and P200DTx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2019to 14 Jan 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
- 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 diagnosed with retinal pathology. Example of pathologies may include but are not limited to Age-related Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy, and others as confirmed by the investigator;
Who cannot join
- Subjects unable to tolerate ophthalmic imaging;
- Subjects with ocular media not sufficiently clear to obtain acceptable images;
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
About this study
Official title: Visualization Study of the UWF (Ultra Wide-field) SLO (Scanning Laser Ophthalmoscope) RG (Red Green), AF (Autofluorescence), FA (Fluorescein Angiography) and ICG ( Indocyanine Green Fluorescence) Images Using the P200TxE (Indy) and P200DTx (California)
The study evaluates image quality between two devices.
- Conditions
- Retinal Disease
- Being tested
- P200TxE, P200DTx
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P200TxEDevice
The P200TxE ophthalmoscope provides widefield scanning laser ophthalmascope (SLO) fundus imaging.
P200DTxDevice
The P200DTx ophthalmoscope provides widefield scanning laser ophthalmascope (SLO) fundus imaging.
| Study group | Role | What they receive |
|---|---|---|
| Ultra widefield image capture | Other | Not described Receives: Device: P200TxE; Device: P200DTx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Image assessment
Results from a qualitative assessment of the clinical utility and image quality of the images from both devices will be assessed from a clinician questionnaire and three independent masked and qualified graders using a four point scale (0-3).
Measured: 6 months
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: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start18 Jun 2019
- Primary completion14 Jan 2020
- Study completion14 Jan 2020
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT03964831
- Sponsor's protocol ID
- OPT1035
- Status last verified
- Sep 2024
- First submitted
- 23 May 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualization Study of the UWF (Ultra Wide-field) SLO (Scanning Laser Ophthalmoscope) RG (Red Green), AF (Autofluorescence), FA (Fluorescein Angiography) and ICG ( Indocyanine Green Fluorescence) Images Using the P200TxE (Indy) and P200DTx (California)
- ClinicalTrials.gov ID
- NCT03964831
- Acronym / sponsor ID
- OPT1035
- Conditions
- Retinal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Optos, PLCIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 28 May 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 study evaluates image quality between two devices.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultra widefield image capture | Other | Device: P200TxE, Device: P200DTx |
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 diagnosed with retinal pathology. Example of pathologies may include but are not limited to Age-related Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy, and others as confirmed by the investigator;
Key exclusion criteria (2 listed)
- Subjects unable to tolerate ophthalmic imaging;
- Subjects with ocular media not sufficiently clear to obtain acceptable 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 |
|---|---|---|
| P200TxEThe P200TxE ophthalmoscope provides widefield scanning laser ophthalmascope (SLO) fundus imaging. | Device | Ultra widefield image capture |
| P200DTxThe P200DTx ophthalmoscope provides widefield scanning laser ophthalmascope (SLO) fundus imaging. | Device | Ultra widefield image capture |
Primary outcome
Qualitative Image assessment
Time frame: 6 months
Results from a qualitative assessment of the clinical utility and image quality of the images from both devices will be assessed from a clinician questionnaire and three independent masked and qualified graders using a four point scale (0-3).
Safety Assessment from Adverse Events
Time frame: 6 months
Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form.
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 19 Sep 2024.
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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 P200TxE and P200DTx 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 19 Sep 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 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 Image assessment (time frame: 6 months). 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 19 Sep 2024.