Normal EyesNCT05844852
P200TE US Reference Database Study
A study testing P200TE in people with Normal Eyes, run by Optos, PLC at 9 sites in United States.
Trial summary
The objective of this study is to collect Optical Coherence Tomography (OCT) data to construct a reference database for the P200TE. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Eyes
- What is being tested?
- P200TE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 954 participants
- Where
- 9 sitesUnited States
- Study dates
- 14 Mar 2023to 13 Sep 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 presenting at the site with normal eyes (Cataracts, LASIK, PRK (photorefractive keratectomy), and peripheral pathology that does not affect the posterior pole region, for example lattice and peripheral drusen, are allowed.
- BCVA (best corrected visual acuity) 20/40 or better(each eye)
- Subject is able to comply with the study procedures
Who cannot join
- Subjects unable to tolerate ophthalmic imaging
- 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
- Subject with ocular media not sufficiently clear toobtain acceptable OCT images
- .History of leukemia, dementia or multiple sclerosis
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Marshall B Ketchum University, Southern California College of Optometry
Anaheim, California, 92807
Specialty Eye Care Centre
Bellevue, Washington, 98004
New England College of Optometry
Boston, Massachusetts, 02215
Illinois College of Optometry
Chicago, Illinois, 60616
State University of New York, Clinical Vision Research
New York, New York, 10036
New England College of Optometry
Roslindale, Massachusetts, 02131
Werner Optometry
San Diego, California, 92019
Eyecare of San Diego
San Diego, California, 92103
Center for Sight
Venice, Florida, 34292
About this study
Official title: Optos P200TE US Reference Database Study
The objective of this study is to collect Optical Coherence Tomography (OCT) data to construct a reference database for the P200TE.
Read the detailed description
The objective of this study is to collect Optical Coherence Tomography (OCT) data on healthy eyes in order to develop a reference database for the P200TE device in order to determine the reference limits for the P200TE
- Conditions
- Normal Eyes
- Being tested
- P200TE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P200TEDevice
The P200TE provides OCT imaging including retinatopography and ONH (optic nerve head) scans.
| Study group | Role | What they receive |
|---|---|---|
| OCT | Other | Device: P200TE The P200TE provides OCT imaging including retina topography and ONH (optic nerve head) scans. Receives: Device: P200TE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal Thickness
The full thickness retina grid consists of a 9-sector circular grid pattern centered on the fovea and based on the ETDRS criteria.
Measured: 1 year
GCC Thickness
The GCC Thickness
Measured: 1 year
RNFL Thickness
The RNFL thickness
Measured: 1 year
Optic Nerve Head
The ONH size
Measured: 1 year
Secondary outcomes (1)
Adverse Events
Number of any adverse events associated with the clinical study to ensure device safety.
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 posted6 May 2023
- Study start14 Mar 2023
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal EyesStudies 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
- 954 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
- NCT05844852
- Sponsor's protocol ID
- OPT1089
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optos P200TE US Reference Database Study
- ClinicalTrials.gov ID
- NCT05844852
- Acronym / sponsor ID
- OPT1089
- Conditions
- Normal Eyes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 954 participants (actual)
- Lead sponsor
- Optos, PLCIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 6 May 2023 (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 objective of this study is to collect Optical Coherence Tomography (OCT) data to construct a reference database for the P200TE.
Detailed description
The objective of this study is to collect Optical Coherence Tomography (OCT) data on healthy eyes in order to develop a reference database for the P200TE device in order to determine the reference limits for the P200TE
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT | Other | Device: P200TEDevice: P200TE The P200TE provides OCT imaging including retina topography and ONH (optic nerve head) scans. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 presenting at the site with normal eyes (Cataracts, LASIK, PRK (photorefractive keratectomy), and peripheral pathology that does not affect the posterior pole region, for example lattice and peripheral drusen, are allowed.
- BCVA (best corrected visual acuity) 20/40 or better(each eye)
- Subject is able to comply with the study procedures
Key exclusion criteria (4 listed)
- Subjects unable to tolerate ophthalmic imaging
- 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
- Subject with ocular media not sufficiently clear toobtain acceptable OCT images
- .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 |
|---|---|---|
| P200TEThe P200TE provides OCT imaging including retinatopography and ONH (optic nerve head) scans. | Device | OCT |
Primary outcome
Retinal Thickness
Time frame: 1 year
The full thickness retina grid consists of a 9-sector circular grid pattern centered on the fovea and based on the ETDRS criteria.
GCC Thickness
Time frame: 1 year
The GCC Thickness
RNFL Thickness
Time frame: 1 year
The RNFL thickness
Optic Nerve Head
Time frame: 1 year
The ONH size
1 secondary outcome
Adverse Events
Time frame: 1 year
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 31 Aug 2026.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P200TE in people with Normal Eyes, run by Optos, PLC at 9 sites 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 5 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: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Retinal Thickness (time frame: 1 year). 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 31 Aug 2026.