NormalNCT05624593
P200TE and Predicate Agreement and Precision Study
A study testing P200TE and Predicate in people with Normal and Retina Disease, 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 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
- Normal, Retina Disease, Glaucoma
- What is being tested?
- P200TE and Predicate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2022to Mar 2023
- 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
Show all 18Show fewer
- BCVA 20/40 or better in the study eye
- History of Visual field defects within the previous year 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 atrophy 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 not able to obtain acceptable OCT images due to ocular media opacity or other reasons
- Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- Presence of any ocular pathology except for cataract in either eye
- Subjects unable to tolerate ophthalmic imaging
- Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
Show all 13Show fewer
- Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- No reliable Humphrey Field Analyzer (HFA) visual field (24-2 Sita Standard or Fast, white on white) result within the past year 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
- Subjects unable to tolerate ophthalmic imaging
- Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
- Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- 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;
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Illinois College of Optometry
Chicago, Illinois, 60616
Elyse Nylin, 312-949-7324, enylin@ico.edu
Michael Chaglasian, OD
About this study
Official title: P200TE Agreement and Precision Study
This study is a prospective comparative, randomized, single center study to assess agreement and precision of the P200TE in comparison to the predicate device in normal subjects, subjects with glaucoma, and subjects with retinal disease.
- Conditions
- Normal, Retina Disease, Glaucoma
- Being tested
- P200TE, Predicate
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P200TEDevice
The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
PredicateDevice
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: P200TE; Device: Predicate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limit of Agreement (LOA) between the P200TE and predicate device measurements of full retinal thickness.
Measured: 1 year
Limit of Agreement (LOA) between the P200TE and predicate device measurements of retinal nerve fiber layer thickness (μm).
Measured: 1 year
Limit of Agreement (LOA) between the P200TE and predicate device measurements of ganglion cell complex thickness (μm).
Measured: 1 year
Limit of Agreement (LOA) between the P200TE and predicate device measurements of optic disc (disc area, rim area, cup-to-disc area, cup-to-disc vertical, cup-to-disc horizontal)
Measured: 1 year
Precision between the P200TE and predicate device measurements of full retinal thickness
Measured: 1 year
Precision between the P200TE and predicate device measurements of retinal nerve fiber layer thickness.
Measured: 1 year
Precision between the P200TE and predicate device measurements of ganglion cell complex thickness
Measured: 1 year
Precision between the P200TE and predicate device measurements of optic disc (disc area, rim area, cup-to-disc area, cup-to-disc vertical, cup-to-disc horizontal)
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 posted22 Nov 2022
- Study start4 Nov 2022
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NormalStudies 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Optos, PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624593
- Sponsor's protocol ID
- OPT1088
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 22 Nov 2022
- 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 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- P200TE Agreement and Precision Study
- ClinicalTrials.gov ID
- NCT05624593
- Acronym / sponsor ID
- OPT1088
- Conditions
- Normal, Retina Disease, Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Optos, PLCIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 22 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.
This study is a prospective comparative, randomized, single center study to assess agreement and precision of the 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: P200TE, Device: Predicate |
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 not able to obtain acceptable OCT images due to ocular media opacity or other reasons
- Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- Presence of any ocular pathology except for cataract in either eye
- 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 |
|---|---|---|
| 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) |
| PredicateThe 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 P200TE and predicate device measurements of full retinal thickness.
Time frame: 1 year
Limit of Agreement (LOA) between the P200TE and predicate device measurements of retinal nerve fiber layer thickness (μm).
Time frame: 1 year
Limit of Agreement (LOA) between the P200TE and predicate device measurements of ganglion cell complex thickness (μm).
Time frame: 1 year
Limit of Agreement (LOA) between the P200TE and predicate device measurements of optic disc (disc area, rim area, cup-to-disc area, cup-to-disc vertical, cup-to-disc horizontal)
Time frame: 1 year
Precision between the P200TE and predicate device measurements of full retinal thickness
Time frame: 1 year
Precision between the P200TE and predicate device measurements of retinal nerve fiber layer thickness.
Time frame: 1 year
Precision between the P200TE and predicate device measurements of ganglion cell complex thickness
Time frame: 1 year
Precision between the P200TE and predicate device measurements of optic disc (disc area, rim area, cup-to-disc area, cup-to-disc vertical, cup-to-disc horizontal)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
Related trials for Normal
RecruitingObservational study
Treatment Effectiveness in People With axSpA or PsA Starting Treatment With Bimekizumab, Risankizumab, Guselkumab, Upadacitinib, or a TNF Inhibitor
Axial Spondylarthritis (axSpA), Psoriatic Arthritis (PsA)
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Enrolling by invitationObservational study
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Primary Immunodeficiency, DOCK8
Enrolling by invitation
Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia
Androgenic Alopecia, Hair Loss/Baldness
RecruitingPhase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Ganglioneuroblastoma, Nodular, Neuroblastoma
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.
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 Predicate in people with Normal and Retina 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 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: status not confirmed, as of the sponsor's last update on 22 Nov 2022. 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?
Contact Eylse Nylin (312-949-7000, enylin@ico.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limit of Agreement (LOA) between the P200TE and predicate device measurements of full retinal thickness. (time frame: 1 year). The study lists 8 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 22 Nov 2022.