Retinal DiseaseNCT03868462
Optos P200TE Agreement and Precision Study
A study testing Optos P200TE and Predicate Device in people with Retinal Disease and Glaucoma, run by Optos, PLC at 1 site in United States.
Trial summary
This study is a prospective comparative, randomized, single center study to assess agreement and precision of the Optos P200TE in comparison to the predicate device in normal subjects, subjects with glaucoma, and subjects with retinal disease. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease, Glaucoma
- What is being tested?
- Optos P200TE and Predicate Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2019to 16 Sep 2019
- 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
- Subjects 22 years of age or older on the date of informed consent
- Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- Subjects with normal eye examinations in both eyes on the date of the study visit as observed with a 90 diopter lens
- BCVA 20/40 or better (each eye) on the date of the study visit
- Subjects 22 years of age or older on the date of informed consent
- Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
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- BCVA 20/40 or better in the study eye
- History of Visual field defects within the previous six (6) months from the study visit or measured the day of the study visit consistent with glaucomatous optic nerve damage with at least one of the following two findings:
- On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;
- Glaucoma hemi-field test "outside normal limits."
- Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
- Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage;
- Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
- Subjects 22 years of age or older on the date of informed consent
- Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- Subjects presenting at the site with retinal disease
- BCVA 20/400 or better in the study eye
- Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration (including patients with drusen and geographic atropy and choroidal neovascularization), Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy and others
Who cannot join
- Subjects unable to tolerate ophthalmic imaging
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in either eye
- Presence of any ocular pathology except for cataract in either eye
- History of leukemia, dementia or multiple sclerosis
- Subjects unable to tolerate ophthalmic imaging
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye
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- No reliable Humphrey Field Analyzer (HFA) visual field (24-2 Sita Standard, white on white) result within 6 months of the study visit, defined as fixation losses > 33% or false positives > 33%, or false negatives > 33% in the study eye
- Presence of any ocular pathology except glaucoma in the study eye
- History of leukemia, dementia or multiple sclerosis
- Subjects unable to tolerate ophthalmic imaging
- Subject with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye
- Presence of glaucoma or any ocular pathology other than a retinal pathology (e.g., cornea pathology) in the study eye as determined by self-report and/or investigator assessment at the study visit;
- History of leukemia, dementia or multiple sclerosis
Trial locations and contacts
1 site in 1 country.
United States1 site
New England Retina Consultants
Springfield, Massachusetts, 01107
About this study
This study is a prospective comparative, randomized, single center study to assess agreement and precision of the Optos P200TE in comparison to the predicate device in normal subjects, subjects with glaucoma, and subjects with retinal disease.
- Conditions
- Retinal Disease, Glaucoma
- Being tested
- Optos P200TE, Predicate Device
- 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.
Optos P200TEDevice
The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
Predicate DeviceDevice
The predicate device is an optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior ocular structures.
| Study group | Role | What they receive |
|---|---|---|
| Optical Coherence Tomography (OCT) | Other | Not described Receives: Device: Optos P200TE; Device: Predicate Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of full retinal thickness (μm).
Measured: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of retinal nerve fiber layer thickness (μm).
Measured: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of ganglion cell complex thickness (μm).
Measured: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of optic disc (area, volume, cup-to-disc ratio).
Measured: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision between the Optos P200TE and predicate device measurements of full retinal thickness.
Measured: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision between the Optos P200TE and predicate device measurements of retinal nerve fiber layer thickness.
Measured: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision between the Optos P200TE and predicate device measurements of ganglion cell complex thickness.
Measured: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision between the Optos P200TE and predicate device measurements of optic disc (area, volume, cup-to-disc ratio).
Measured: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision of the P200TE for the super pixel grid measurements of the full retinal thickness.
Measured: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision of the P200TE for the super pixel grid measurements of the RNFL thickness.
Measured: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision of the P200TE for the super pixel grid measurements of GCC thickness.
Measured: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start11 Feb 2019
- Primary completion16 Sep 2019
- Study completion16 Sep 2019
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
- 137 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
- NCT03868462
- Sponsor's protocol ID
- OPT1029
- Status last verified
- Oct 2019
- First submitted
- 2 Mar 2019
- Last updated
- 15 Oct 2019
- 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 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optos P200TE Agreement and Precision Study
- ClinicalTrials.gov ID
- NCT03868462
- Acronym / sponsor ID
- OPT1029
- Conditions
- Retinal Disease, Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Optos, PLCIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 11 Mar 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.
This study is a prospective comparative, randomized, single center study to assess agreement and precision of the Optos P200TE in comparison to the predicate device in normal subjects, subjects with glaucoma, and subjects with retinal disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optical Coherence Tomography (OCT) | Other | Device: Optos P200TE, Device: Predicate Device |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subjects 22 years of age or older on the date of informed consent
- Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- Subjects with normal eye examinations in both eyes on the date of the study visit as observed with a 90 diopter lens
- BCVA 20/40 or better (each eye) on the date of the study visit
- Subjects 22 years of age or older on the date of informed consent
Key exclusion criteria (13 listed)
- Subjects unable to tolerate ophthalmic imaging
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in either eye
- Presence of any ocular pathology except for cataract in either eye
- History of leukemia, dementia or multiple sclerosis
- Subjects unable to tolerate ophthalmic imaging
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 |
|---|---|---|
| Optos P200TEThe P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device. | Device | Optical Coherence Tomography (OCT) |
| Predicate DeviceThe predicate device is an optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior ocular structures. | Device | Optical Coherence Tomography (OCT) |
Primary outcome
Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of full retinal thickness (μm).
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of retinal nerve fiber layer thickness (μm).
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of ganglion cell complex thickness (μm).
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of optic disc (area, volume, cup-to-disc ratio).
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision between the Optos P200TE and predicate device measurements of full retinal thickness.
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision between the Optos P200TE and predicate device measurements of retinal nerve fiber layer thickness.
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision between the Optos P200TE and predicate device measurements of ganglion cell complex thickness.
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision between the Optos P200TE and predicate device measurements of optic disc (area, volume, cup-to-disc ratio).
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision of the P200TE for the super pixel grid measurements of the full retinal thickness.
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision of the P200TE for the super pixel grid measurements of the RNFL thickness.
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision of the P200TE for the super pixel grid measurements of GCC thickness.
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
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 15 Oct 2019.
- 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 Optos P200TE and Predicate Device 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 18 inclusion and 13 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 15 Oct 2019. 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?
Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of full retinal thickness (μm). (time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)). The study lists 11 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 15 Oct 2019.