Performance Evaluation of Dream OCT: AP Study

NCT07355491 | Recruiting FDA Device

• 1 other identifier: DREAM-CP2025-001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Normal Healthy Eyes; Glaucoma Patients; Retina Patients; Eyes With Corneal Abnormality

Keywords

Eyes with ocular pathology and normal healthy eyes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Device Safety

  the study duration is approximately 6 months

Study Arms (4)

Normal Healthy Eyes

Eyes without pathology

Device: This is an observational study only, all patients are imaged on the investigational 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

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

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

Interventions

This is an observational study only, all patients are imaged on the investigational device DEVICE

This study is a non-significant risk study where enrolled patients are imaged on an investigational device and a predicate device

Cornea; Glaucoma; Normal Healthy Eyes; Retina

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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 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 20/40 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 unable to tolerate ophthalmic imaging
• Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons

Sponsors & Collaborators

• Illinois College of Optometry: collaborator
• Intalight, Inc: lead

Study Sites (1)

Illinois College of Optometry

Chicago, Illinois, 60616, United States

RECRUITING

Study Officials

• Micahel Chaglasian, OD

  Illinois College of Optometry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mike Sinai, PhD

CONTACT

6198067636; mike.sinai@intalight.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: December 16, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)