GlaucomaNCT06135727
Screening Protocol
An observational study of Glaucoma, run by Topcon Corporation at 1 site in United States.
Trial summary
The objective of this study is to collect data for the development and validation a screening process using aggregate data. In this study, data collection will encompass both retrospective and prospective approaches across multiple sites in the United States. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Maestro2 OCT
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2023to 2 Aug 2024
- Phase
- Observational
- 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
Study population: Subjects with normal eyes and eyes with moderate or severe glaucoma
Who may be able to join
- Subjects 22 years of age or older on the date of data collection (retrospective) or informed consent (prospective).
- For prospective data collection or missing retrospective data collection, subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent.
- BCVA 20/40 or better (each eye).
- Normal eyes to have normal ocular examination in both eyes
- Normal eyes to have IOP ≤ 21 mmHg in both eyes
- Pathology eyes to have clinical diagnosis of mild or moderate glaucoma in at least one eye
Who cannot join
- For prospective or missing retrospective data collection, subjects unable to tolerate ophthalmic testing.
- Concomitant diseases known to affect the visual field: history of leukemia, dementia, Parkinson's disease, Alzheimer's disease, stroke, or autoimmune diseases.
- History of intraocular surgery (uncomplicated cataract or glaucoma surgeries are accepted)
- Ocular findings or history of co-morbidities, including, but not limited to: uveitis, non-glaucomatous optic neuropathy, trauma, retinal detachment, vein or artery occlusions, wet age-related macular degeneration, geographic atrophy, proliferative diabetic retinopathy, vitreous hemorrhage, severe cataract, severe non-proliferative diabetic retinopathy. Controlled diabetes and hypertension participants can be included.
- Unreliable VF testing and/or poor-quality OCT scans.
- Poor fixation.
Show all 9Show fewer
- Pathology eyes with severe glaucoma
- Pathology eyes with glaucoma suspect diagnosis
- Pathology eyes with Ocular Hypertensive diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Data Collection for Development of Topcon Health Score
The objective of this study is to collect data for the development and validation a screening process using aggregate data.
In this study, data collection will encompass both retrospective and prospective approaches across multiple sites in the United States.
- Conditions
- Glaucoma
- Being tested
- Maestro2 OCT
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maestro2 OCTDevice
3D Wide (12mmx9mm) OCT scan using the Maestro (Topcon, Japan)
| Study group | Role | What they receive |
|---|---|---|
| Pathology (glaucoma) arm | Not described Receives: Device: Maestro2 OCT | |
| Normal arm | Not described Receives: Device: Maestro2 OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
RNFL and GCL thickness
Using Maestro2 OCT
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start7 Nov 2023
- Primary completion2 Aug 2024
- Study completion2 Aug 2024
Why it stopped: limited access to study population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topcon Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Durbin, PhD, Study chair, Topcon CorporationNevin W. El-Nimri, OD, PhD, Principal investigator, Topcon Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135727
- Sponsor's protocol ID
- TPCN-2023-001
- Status last verified
- Dec 2024
- First submitted
- 13 Nov 2023
- Last updated
- 10 Sep 2025
- 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 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection for Development of Topcon Health Score
- ClinicalTrials.gov ID
- NCT06135727
- Acronym / sponsor ID
- TPCN-2023-001
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: limited access to study population
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Topcon CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 18 Nov 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 data for the development and validation a screening process using aggregate data.
In this study, data collection will encompass both retrospective and prospective approaches across multiple sites in the United States.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pathology (glaucoma) arm | – | Device: Maestro2 OCT |
| Normal arm | – | Device: Maestro2 OCT |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with normal eyes and eyes with moderate or severe glaucoma
Key inclusion criteria (6 listed)
- Subjects 22 years of age or older on the date of data collection (retrospective) or informed consent (prospective).
- For prospective data collection or missing retrospective data collection, subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent.
- BCVA 20/40 or better (each eye).
- Normal eyes to have normal ocular examination in both eyes
- Normal eyes to have IOP ≤ 21 mmHg in both eyes
Key exclusion criteria (9 listed)
- For prospective or missing retrospective data collection, subjects unable to tolerate ophthalmic testing.
- Concomitant diseases known to affect the visual field: history of leukemia, dementia, Parkinson's disease, Alzheimer's disease, stroke, or autoimmune diseases.
- History of intraocular surgery (uncomplicated cataract or glaucoma surgeries are accepted)
- Ocular findings or history of co-morbidities, including, but not limited to: uveitis, non-glaucomatous optic neuropathy, trauma, retinal detachment, vein or artery occlusions, wet age-related macular degeneration, geographic atrophy, proliferative diabetic retinopathy, vitreous hemorrhage, severe cataract, severe non-proliferative diabetic retinopathy. Controlled diabetes and hypertension participants can be included.
- Unreliable VF testing and/or poor-quality OCT scans.
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 |
|---|---|---|
| Maestro2 OCT3D Wide (12mmx9mm) OCT scan using the Maestro (Topcon, Japan) | Device | Normal arm, Pathology (glaucoma) arm |
Primary outcome
RNFL and GCL thickness
Time frame: 1 day
Using Maestro2 OCT
Results and safety
The study was stopped early (reason given: limited access to study population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Not yet recruitingPhase 2
VGFTe-(HD)-OD-2566: Adjunctive Aflibercept Ahmed Glaucoma Valve (AAA) Study
Glaucoma
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Recruiting
Timing of Glaucoma Drainage Device With Boston Keratoprosthesis
Corneal Transplantation, Glaucoma
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.
Mary Durbin, PhD study chair
Topcon Corporation
Nevin W. El-Nimri, OD, PhD principal investigator
Topcon Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Topcon Corporation 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 9 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: stopped early, as of the sponsor's last update on 10 Sep 2025. 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 was stopped early (reason given: limited access to study population). Results are not available in the source record.
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?
RNFL and GCL thickness (time frame: 1 day). 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 10 Sep 2025.