Glaucoma PatientsNCT07355491
Performance Evaluation of Dream OCT: AP Study
An observational study of Glaucoma Patients and Retina Patients, run by Intalight, Inc at 1 site in United States.
Trial summary
This study will evaluate the clinical performance of a new swept-source OCT imaging device, the VG200D, and to evaluate substantial equivalence with a predicate device, the Cirrus 5000. Clinical performance will be assessed through an agreement and precision analysis of OCT measurement parameters. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma Patients, Retina Patients, Eyes With Corneal Abnormality
- What is being tested?
- This is an observational study only, all patients are imaged on the investigational device
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2025to 12 May 2026
- 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: Study population includes patients with normal healthy eyes, patients with glaucoma, patients with retina pathology and patients with abnormal corneas
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 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
- 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, Vein or artery Occlusions and others
- 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 one of the following corneal abnormalities:
- Cornea disease (e.g., Fuch's or other) ii. Keratoconus iii. Cornea transplant iv. Post refractive surgery (e.g., LASIK or other) v. Dry Eye Syndrome vi. Long-term contact wearers (greater than 1 year)
- BCVA 20/400 or better in the study eye
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
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- 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, 10-2, 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
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Illinois College of Optometry
Chicago, Illinois, 60616
About this study
This study will evaluate the clinical performance of a new swept-source OCT imaging device, the VG200D, and to evaluate substantial equivalence with a predicate device, the Cirrus 5000. Clinical performance will be assessed through an agreement and precision analysis of OCT measurement parameters.
Read the detailed description
The goal of this study is to evaluate the clinical performance of a new swept-source OCT imaging device, the VG200D, and to evaluate substantial equivalence with a predicate device, the Cirrus 5000. Clinical performance will be assessed through an agreement and precision analysis of OCT measurement parameters. Evidence for substantial equivalence will be through establishing equivalent precision results between devices and meeting pre-determined performance goals for precision and agreement results for a majority of parameters.
The primary objective of this study is to evaluate agreement and precision of measurements between the VG200D and the predicate device Cirrus.
Primary endpoints include the agreement and precision results from the Anterior Segment OCT measurements for cornea and epithelial thickness in normal eyes and eyes with a corneal abnormality and the posterior segment OCT measurements for the retina, ganglion cell +IPL, RNFL, and optic nerve in normal eyes, eyes with glaucoma, and eyes with retinal pathology.
This is a prospective comparative study that will be conducted at one clinical site in the United States, in which subjects who sign an informed consent form and fulfil all inclusion and exclusion criteria will have images obtained using the study device and the predicate device (VG200D and Cirrus respectively).
Subjects enrolled in this study will be confirmed to have normal healthy eyes, eyes with retina pathology, eyes with glaucoma, or eyes with cornea abnormality. Ocular status will be determined by a thorough clinical examination after enrollment. Except for normal eyes, subjects enrolled may have more than one ocular pathology. If subjects have more than one ocular pathology, the investigator will enroll them in the study group based on the ocular pathology that is more clinically significant (more severe).
There will be two main types of analyses performed as part of this study, including 1) a precision analysis, and 2) an agreement analysis.
- Being tested
- This is an observational study only, all patients are imaged on the investigational device
- Keywords
- Eyes with ocular pathology and normal healthy eyes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational study only, all patients are imaged on the investigational deviceDevice
This study is a non-significant risk study where enrolled patients are imaged on an investigational device and a predicate device
| Study group | Role | What they receive |
|---|---|---|
| Normal Healthy Eyes | Eyes without pathology Receives: Device: This is an observational study only, all patients are imaged on the investigational device | |
| Glaucoma | Patients with glaucoma in one or both eyes Receives: Device: This is an observational study only, all patients are imaged on the investigational device | |
| Retina | Patients with retina pathology in one or both eyes Receives: Device: This is an observational study only, all patients are imaged on the investigational device | |
| Cornea | Eyes with cornea abnormality in one or both eyes Receives: Device: This is an observational study only, all patients are imaged on the investigational device |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCT Measurement Agreement between OCT devices and measurement Precision Results
Primary endpoints include the agreement and precision results from the Anterior Segment OCT measurements for cornea and epithelial thickness in normal eyes and eyes with a corneal abnormality and the posterior segment OCT measurements for the retina, ganglion cell +IPL, RNFL, and optic nerve in normal eyes, eyes with glaucoma, and eyes with retinal pathology.
Measured: This study will last approximately 6 months
Secondary outcomes (1)
Device and Patient Safety determined through monitoring of adverse events
Any and all adverse events associated with this study will be reported
Measured: the study duration is approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start16 Dec 2025
- Primary completion12 May 2026
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma PatientsStudies 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
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intalight, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Illinois College of Optometry
- Responsible party
- Sponsor
- Investigators
- Micahel Chaglasian, OD, Principal investigator, Illinois College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355491
- Sponsor's protocol ID
- DREAM-CP2025-001
- Status last verified
- Jul 2026
- First submitted
- 12 Jan 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The study data will be used for an FDA 510k filing
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of Dream OCT: AP Study
- ClinicalTrials.gov ID
- NCT07355491
- Acronym / sponsor ID
- DREAM-CP2025-001
- Keywords
- Eyes with ocular pathology and normal healthy eyes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Intalight, IncIndustry (pharma, biotech, devices)
- Collaborators
- Illinois College of Optometry
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 21 Jan 2026 (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 will evaluate the clinical performance of a new swept-source OCT imaging device, the VG200D, and to evaluate substantial equivalence with a predicate device, the Cirrus 5000. Clinical performance will be assessed through an agreement and precision analysis of OCT measurement parameters.
Detailed description
The goal of this study is to evaluate the clinical performance of a new swept-source OCT imaging device, the VG200D, and to evaluate substantial equivalence with a predicate device, the Cirrus 5000. Clinical performance will be assessed through an agreement and precision analysis of OCT measurement parameters. Evidence for substantial equivalence will be through establishing equivalent precision results between devices and meeting pre-determined performance goals for precision and agreement results for a majority of parameters.
The primary objective of this study is to evaluate agreement and precision of measurements between the VG200D and the predicate device Cirrus.
Primary endpoints include the agreement and precision results from the Anterior Segment OCT measurements for cornea and epithelial thickness in normal eyes and eyes with a corneal abnormality and the posterior segment OCT measurements for the retina, ganglion cell +IPL, RNFL, and optic nerve in normal eyes, eyes with glaucoma, and eyes with retinal pathology.
This is a prospective comparative study that will be conducted at one clinical site in the United States, in which subjects who sign an informed consent form and fulfil all inclusion and exclusion criteria will have images obtained using the study device and the predicate device (VG200D and Cirrus respectively).
Subjects enrolled in this study will be confirmed to have normal healthy eyes, eyes with retina pathology, eyes with glaucoma, or eyes with cornea abnormality. Ocular status will be determined by a thorough clinical examination after enrollment. Except for normal eyes, subjects enrolled may have more than one ocular pathology. If subjects have more than one ocular pathology, the investigator will enroll them in the study group based on the ocular pathology that is more clinically significant (more severe).
There will be two main types of analyses performed as part of this study, including 1) a precision analysis, and 2) an agreement analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Healthy Eyes | – | Device: This is an observational study only, all patients are imaged on the investigational deviceEyes without pathology |
| Glaucoma | – | Device: This is an observational study only, all patients are imaged on the investigational devicePatients with glaucoma in one or both eyes |
| Retina | – | Device: This is an observational study only, all patients are imaged on the investigational devicePatients with retina pathology in one or both eyes |
| Cornea | – | Device: This is an observational study only, all patients are imaged on the investigational deviceEyes with cornea abnormality in one or both eyes |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population includes patients with normal healthy eyes, patients with glaucoma, patients with retina pathology and patients with abnormal corneas
Key inclusion criteria (22 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 (14 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 |
|---|---|---|
| This is an observational study only, all patients are imaged on the investigational deviceThis study is a non-significant risk study where enrolled patients are imaged on an investigational device and a predicate device | Device | Cornea, Glaucoma, Normal Healthy Eyes, Retina |
Primary outcome
OCT Measurement Agreement between OCT devices and measurement Precision Results
Time frame: This study will last approximately 6 months
Primary endpoints include the agreement and precision results from the Anterior Segment OCT measurements for cornea and epithelial thickness in normal eyes and eyes with a corneal abnormality and the posterior segment OCT measurements for the retina, ganglion cell +IPL, RNFL, and optic nerve in normal eyes, eyes with glaucoma, and eyes with retinal pathology.
1 secondary outcome
Device and Patient Safety determined through monitoring of adverse events
Time frame: the study duration is approximately 6 months
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 29 Jul 2026.
- Individual participant dataSharing planned: No. The study data will be used for an FDA 510k filing
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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.
Micahel Chaglasian, OD principal investigator
Illinois College of Optometry
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 Patients and Retina Patients, run by Intalight, Inc 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 22 inclusion and 14 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 29 Jul 2026. 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?
OCT Measurement Agreement between OCT devices and measurement Precision Results (time frame: This study will last approximately 6 months). 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 29 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.