Performance Evaluation of Dream OCT: AP 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.

Study Overview

• Status: Recruiting
• Conditions: Normal Healthy Eyes; Eyes With Corneal Abnormality; Glaucoma Patients; Retina Patients
• Intervention / Treatment: Device: This is an observational study only, all patients are imaged on the investigational device

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: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Mike Sinai, PhD; Phone Number: 6198067636; Email: mike.sinai@intalight.com

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Recruiting
      • Illinois College of Optometry
      • Contact: Jessica Martinez, BA; Phone Number: (312) 949-7000; Email: jemartinez@ico.edu
      • Contact: Elyse Nylin, BA; Phone Number: (312) 949-7000; Email: enylin@ico.edu
      • Principal Investigator: Micahel Chaglasian, OD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Agreement results and 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.	This study will last approximately 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Safety	Any and all adverse events associated with this study will be reported	the study duration is approximately 6 months

Collaborators and Investigators

• Sponsor: Intalight, Inc
• Collaborators: Illinois College of Optometry
• Investigators: Principal Investigator: Micahel Chaglasian, OD, Illinois College of Optometry

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Eyes with ocular pathology and normal healthy eyes
• Other Study ID 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