Performance Evaluation of Dream OCT: AP Study

January 12, 2026 updated by: Intalight, Inc
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Recruiting
        • Illinois College of Optometry
        • Contact:
        • Contact:
        • Principal Investigator:
          • Micahel Chaglasian, OD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Study population includes patients with normal healthy eyes, patients with glaucoma, patients with retina pathology and patients with abnormal corneas

Description

Inclusion Criteria for Normal Group:

  1. Subjects 22 years of age or older on the date of informed consent
  2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  3. Subjects with normal eye examinations in both eyes on the date of the study visit as observed with a 90 diopter lens
  4. BCVA 20/40 or better (each eye) on the date of the study visit

Exclusion Criteria for Normal Group:

  1. Subjects unable to tolerate ophthalmic imaging
  2. Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
  3. 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
  4. Presence of any ocular pathology except for cataract in either eye

Inclusion Criteria for Glaucoma Group:

  1. Subjects 22 years of age or older on the date of informed consent
  2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  3. BCVA 20/40 or better in the study eye

  4. 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:

    1. 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;
    2. Glaucoma hemi-field test "outside normal limits."

  5. Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:

    1. Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage;
    2. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue

Exclusion Criteria for Glaucoma Group:

  1. Subjects unable to tolerate ophthalmic imaging
  2. Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
  3. 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
  4. 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

Inclusion Criteria for Retina Disease Group:

  1. Subjects 22 years of age or older on the date of informed consent
  2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  3. BCVA 20/400 or better in the study eye
  4. 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

Exclusion Criteria for Retinal Disease Group:

  1. Subjects unable to tolerate ophthalmic imaging
  2. Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
  3. 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

Inclusion Criteria for Cornea Group:

  1. Subjects 22 years of age or older on the date of informed consent
  2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent

  3. Subjects with one of the following corneal abnormalities:

    i. 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)

  4. BCVA 20/400 or better in the study eye

Exclusion Criteria for Cornea Group:

  1. Subjects unable to tolerate ophthalmic imaging
  2. Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
  3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Normal Healthy Eyes
Eyes without pathology
Device: This is an observational study only, all patients are imaged on the investigational device
This study is a non-significant risk study where enrolled patients are imaged on an investigational device and a predicate device
Glaucoma
Patients with glaucoma in one or both eyes
Device: This is an observational study only, all patients are imaged on the investigational device
This study is a non-significant risk study where enrolled patients are imaged on an investigational device and a predicate device
Retina
Patients with retina pathology in one or both eyes
Device: This is an observational study only, all patients are imaged on the investigational device
This study is a non-significant risk study where enrolled patients are imaged on an investigational device and a predicate device
Cornea
Eyes with cornea abnormality in one or both eyes
Device: This is an observational study only, all patients are imaged on the investigational device
This study is a non-significant risk study where enrolled patients are imaged on an investigational device and a predicate device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Agreement results and 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.
This study will last approximately 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device Safety
Time Frame: the study duration is approximately 6 months
Any and all adverse events associated with this study will be reported
the study duration is approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intalight, Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Illinois College of Optometry

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Micahel Chaglasian, OD, Illinois College of Optometry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DREAM-CP2025-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study data will be used for an FDA 510k filing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

Rare Diseases

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Dietary Supplements

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