The Focus of This Study is to Collect OCT Data on Normal EyesNCT07751484
Intalight Reference Database Protocol for VG200D
An observational study of The Focus of This Study is to Collect OCT Data on Normal Eyes, run by Intalight, Inc at 3 sites in United States.
Trial summary
The goal of this study is to collect OCT scans on normal healthy eyes from an investigational OCT device the VG200D from Intalight, Inc, in order to establish a reference database. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Focus of This Study is to Collect OCT Data on Normal Eyes
- What is being tested?
- OCT device called VG200D
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Jul 2026to 15 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: A total of approximately 350 subjects without ocular pathology will be enrolled in this study from 3 clinical sites. Subjects will include a diverse range of races and ethnicities and should reflect or generally approximate the general population of the US. The average age of all subjects will be approximately 55-60 years of age or older. The age distribution will be similar to the table below. Percent 5 10 20 25 25 15 Total # 18 35 70 87 88 52 Age 22-30 31-40 41-50 51-60 61-70 71+ Table1. The age distribution of the study participants along with the percentage for each age group and the total number of subjects for each age group to be enrolled. The following seven categories on race and ethnicity were identified and defined and will be used in this study*: * American Indian or Alaska Native * Asian * Black or African American * Hispanic or Latino * Middle Eastern or North African * Native Hawaiian or Pacific Islander * White
Who may be able to join
- 1. Subject 22 years of age or older on the date of informed consent 2. Subject able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3. Subjects presenting at the site with normal eyes. Cataracts, LASIK, PRK, and peripheral pathology that does not affect the posterior pole region, for example lattice and peripheral drusen, are allowed.
- 4. BCVA 20/40 or better (each eye) 5. Subject is able to comply with the study procedures
Who cannot join
- 1. Subject unable to tolerate ophthalmic imaging 2. Subject has an ocular pathology other than cataract or mild peripheral, age-related changes (e.g., peripheral drusen, lattice, etc.) 3. Glaucoma diagnosis in either eye. 4. 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 5. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Indiana University - School of Optometry
Bloomington, Indiana, 47405
Brett King, OD, 812-855-4447, kingbrj@iu.edu
Brett King, OD
- Recruiting
Illinois College of Optometry
Chicago, Illinois, 60616
Michael Chaglasian, OD, 312-949-7000, mchaglas@ico.edu
Michael Chaglasian, OD
- Recruiting
New View Optometry
San Diego, California, 91942
David Kasanoff, OD, 619-465-7900, davksnf@gmail.com
David Kasanoff, OD
About this study
The goal of this study is to collect OCT scans on normal healthy eyes from an investigational OCT device the VG200D from Intalight, Inc, in order to establish a reference database. The reference database will be used to establish normal ranges for thickness measurement parameters provided by the VG200D OCT software including anterior segment and posterior segment measurements. The study will enroll normal eyes from three clinics in the US including a wide range of ages and races/ethnicities.
Read the detailed description
The goal of this study is to capture VG200D OCT and OCTA scans on at least 350 normal, healthy eyes from individuals with an average age between 55-60 years of age that come from a wide range of ethnicities and races to roughly approximate the US population. This data will be used to create distribution curves for each measurement parameter and to determine the cut-off values at the 1%, 5%, 95% and 99% values for each measurement parameter. Cut-off values will be determined using a non-parametric method based on the distribution directly. Each measurement parameter distribution and associated cut-off values will be used to create a 'Reference Database' that will be used to provide feedback to clinicians using the device. When the user captures a scan on a patient, the software will indicate where a given measurement value falls within this distribution. Values between the 5% and 95% are colored green and labelled 'within normal limits', values between the 1% and 5% and between the 95% and 99% are colored yellow and labelled 'borderline', and values below the 1% and above the 99% are colored red and labelled 'outside normal limits'. These classifications aid the clinician in interpretation of the scan data by providing information where a given patient falls within the Reference Database distribution. These values are based on a comparison to the Reference Database and should be used to aid clinical decisions in combination with other clinical information available, they should not be used as the sole basis for clinical decisions.
- Being tested
- OCT device called VG200D
- Keywords
- Optical Coherence Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT device called VG200DDevice
This is an investigational imaging device
| Study group | Role | What they receive |
|---|---|---|
| Normal | This group includes subjects with normal healthy eyes as confirmed by a clinical examination by trained eye-care professionals Receives: Device: OCT device called VG200D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative ocular structures
Retinal structural measurements of the anterior and posterior segments of the eye
Measured: this study will alst 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 posted7 Aug 2026
- Study start8 Jul 2026
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Focus of This Study is to Collect OCT Data on 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intalight, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Illinois College of Optometry
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751484
- Sponsor's protocol ID
- DREAM-RDB1-2026-003
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All data will be kept confidential to the site and the Sponsor
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intalight Reference Database Protocol for VG200D
- ClinicalTrials.gov ID
- NCT07751484
- Acronym / sponsor ID
- DREAM-RDB1-2026-003
- Keywords
- Optical Coherence Tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Intalight, IncIndustry (pharma, biotech, devices)
- Collaborators
- Illinois College of Optometry
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 7 Aug 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.
The goal of this study is to collect OCT scans on normal healthy eyes from an investigational OCT device the VG200D from Intalight, Inc, in order to establish a reference database. The reference database will be used to establish normal ranges for thickness measurement parameters provided by the VG200D OCT software including anterior segment and posterior segment measurements. The study will enroll normal eyes from three clinics in the US including a wide range of ages and races/ethnicities.
Detailed description
The goal of this study is to capture VG200D OCT and OCTA scans on at least 350 normal, healthy eyes from individuals with an average age between 55-60 years of age that come from a wide range of ethnicities and races to roughly approximate the US population. This data will be used to create distribution curves for each measurement parameter and to determine the cut-off values at the 1%, 5%, 95% and 99% values for each measurement parameter. Cut-off values will be determined using a non-parametric method based on the distribution directly. Each measurement parameter distribution and associated cut-off values will be used to create a 'Reference Database' that will be used to provide feedback to clinicians using the device. When the user captures a scan on a patient, the software will indicate where a given measurement value falls within this distribution. Values between the 5% and 95% are colored green and labelled 'within normal limits', values between the 1% and 5% and between the 95% and 99% are colored yellow and labelled 'borderline', and values below the 1% and above the 99% are colored red and labelled 'outside normal limits'. These classifications aid the clinician in interpretation of the scan data by providing information where a given patient falls within the Reference Database distribution. These values are based on a comparison to the Reference Database and should be used to aid clinical decisions in combination with other clinical information available, they should not be used as the sole basis for clinical decisions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Device: OCT device called VG200DThis group includes subjects with normal healthy eyes as confirmed by a clinical examination by trained eye-care professionals |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of approximately 350 subjects without ocular pathology will be enrolled in this study from 3 clinical sites. Subjects will include a diverse range of races and ethnicities and should reflect or generally approximate the general population of the US. The average age of all subjects will be approximately 55-60 years of age or older. The age distribution will be similar to the table below. Percent 5 10 20 25 25 15 Total # 18 35 70 87 88 52 Age 22-30 31-40 41-50 51-60 61-70 71+ Table1. The age distribution of the study participants along with the percentage for each age group and the total number of subjects for each age group to be enrolled. The following seven categories on race and ethnicity were identified and defined and will be used in this study*: * American Indian or Alaska Native * Asian * Black or African American * Hispanic or Latino * Middle Eastern or North African * Native Hawaiian or Pacific Islander * White
Key inclusion criteria (2 listed)
- 1. Subject 22 years of age or older on the date of informed consent 2. Subject able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3. Subjects presenting at the site with normal eyes. Cataracts, LASIK, PRK, and peripheral pathology that does not affect the posterior pole region, for example lattice and peripheral drusen, are allowed.
- 4. BCVA 20/40 or better (each eye) 5. Subject is able to comply with the study procedures
Key exclusion criteria (1 listed)
- 1. Subject unable to tolerate ophthalmic imaging 2. Subject has an ocular pathology other than cataract or mild peripheral, age-related changes (e.g., peripheral drusen, lattice, etc.) 3. Glaucoma diagnosis in either eye. 4. 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 5. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
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 |
|---|---|---|
| OCT device called VG200DThis is an investigational imaging device | Device | Normal |
Primary outcome
Quantitative ocular structures
Time frame: this study will alst approximately 6 months
Retinal structural measurements of the anterior and posterior segments of the eye
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No. All data will be kept confidential to the site and the Sponsor
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Focus of This Study is to Collect OCT Data on Normal Eyes, run by Intalight, Inc at 3 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 7 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 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mike Sinai, PhD (6198067636, mike.sinai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative ocular structures (time frame: this study will alst 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 7 Aug 2026.