Retinal DiseaseNCT02921568
Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes
A study testing P200TE and Spectral OCT/SLO in people with Retinal Disease and Glaucoma, run by Optos, PLC at 1 site in United States.
Trial summary
This study is designed to evaluate and compare in-tissue performance of OCT scans on the new Optos P200TE, versus the predicate Optos Spectral OCT/SLO device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Disease, Glaucoma
- What is being tested?
- P200TE and Spectral OCT/SLO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 18 years of age or older who have full legal capacity to volunteer;
- Subjects who have signed the informed consent;
- Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
- Subjects who agree to participate in the study;
- Subjects with current BSCVA 20/400 or better in the ocular disease study eye(s);
- Subjects diagnosed with ocular disease including but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Central Serous Retinopathy, Macular Hole, Epiretinal Membrane, Macular Edema, Glaucoma, and others in the retinal disease study eye(s) as confirmed at the study visit or within the past six (6) months.
Who cannot join
- Subjects unable to tolerate ophthalmic imaging;
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
- Subjects without ocular disease in study eye(s), as determined by self-report and/or investigator assessment at the study visit;
- Subjects with history of leukemia, dementia or multiple sclerosis.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Cathy Ellis, BS, MT, 210-697-2036 ext. 2270, cathy@mcoaeyecare.com
Michael Singer, MD
About this study
This study is designed to evaluate and compare in-tissue performance of OCT scans on the new Optos P200TE, versus the predicate Optos Spectral OCT/SLO device.
- Conditions
- Retinal Disease, Glaucoma
- Being tested
- P200TE, Spectral OCT/SLO
- Medical subject headings
- Retinal Diseases, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P200TEDevice
Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.
Spectral OCT/SLODevice
Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | All patients will be imaged on the P200TE and Spectral OCT/SLO devices. Receives: Device: P200TE; Device: Spectral OCT/SLO |
What is being measured
The primary outcome is the main question the study is designed to answer.
retinal thickness
Measured: completion of the study, up to 5 years
Retinal Nerve Fibre Layer Thickness
Measured: completion of the study, up to 5 years
Optic Nerve Head Topography
Measured: completion of the study, up to 5 years
Cup/Disc Ratio
Measured: completion of the study, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Optos, PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Optos, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921568
- Sponsor's protocol ID
- OPT1018
- Status last verified
- Sep 2016
- First submitted
- 16 Sep 2016
- Last updated
- 14 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes
- ClinicalTrials.gov ID
- NCT02921568
- Acronym / sponsor ID
- OPT1018
- Conditions
- Retinal Disease, Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Optos, PLCIndustry (pharma, biotech, devices)
- Collaborators
- Optos, Inc.
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (estimated)
- First posted
- 3 Oct 2016 (estimated)
- 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 evaluate and compare in-tissue performance of OCT scans on the new Optos P200TE, versus the predicate Optos Spectral OCT/SLO device.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Device: P200TE, Device: Spectral OCT/SLOAll patients will be imaged on the P200TE and Spectral OCT/SLO devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects 18 years of age or older who have full legal capacity to volunteer;
- Subjects who have signed the informed consent;
- Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
- Subjects who agree to participate in the study;
- Subjects with current BSCVA 20/400 or better in the ocular disease study eye(s);
Key exclusion criteria (4 listed)
- Subjects unable to tolerate ophthalmic imaging;
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
- Subjects without ocular disease in study eye(s), as determined by self-report and/or investigator assessment at the study visit;
- Subjects with 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 |
|---|---|---|
| P200TEOptical Coherence Tomography and Scanning Laser Ophthalmoscope device. | Device | All patients |
| Spectral OCT/SLOOptical Coherence Tomography and Scanning Laser Ophthalmoscope device. | Device | All patients |
Primary outcome
retinal thickness
Time frame: completion of the study, up to 5 years
Retinal Nerve Fibre Layer Thickness
Time frame: completion of the study, up to 5 years
Optic Nerve Head Topography
Time frame: completion of the study, up to 5 years
Cup/Disc Ratio
Time frame: completion of the study, up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
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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.
Medical Center Ophthalmology Associates
San Antonio, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P200TE and Spectral OCT/SLO in people with Retinal Disease and Glaucoma, 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 6 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: status not confirmed, as of the sponsor's last update on 14 Mar 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retinal thickness (time frame: completion of the study, up to 5 years). The study lists 4 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 14 Mar 2017.