NCT07355491

Performance Evaluation of Dream OCT: AP Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Intalight, Inc · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-16
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study