Swept Source OCT Imaging With the DREAM VG-OCT

The Intalight Dream OCT is the first combo anterior plus posterior device to perform both OCT and OCT-A at depth of 16mm. This is especially useful in patient who are very nearsighted as it allows us to image all in one frame. The intention of this study is to see how the images differ on the same patients when compared to the Cirrus OCT and to test for the repeatability of the images on a single day.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Eye Diseases; Myopia
• Intervention / Treatment: Device: DREAM OCT

• Study Type: Observational
• Enrollment (Actual): 154

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Byers Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The investigators will be imaging 100 eyes (50 patients unless there are monocular patients) from all genders and ethnic backgrounds who are moderate-high myopes with or without the diagnosis of glaucoma.

Description

Inclusion Criteria:

• Age greater than or equal to 18
• Myopes with a current or previously documented spherical equivalent refraction < -4D
• At least half of the subjects should have had at least one Cirrus OCT RNFL and macula performed as well as a Humphrey visual field performed in those with OCT abnormalities

Exclusion Criteria:

• Unable to comply with study imaging
• unclear ocular media
• Participant has, in the opinion of the investigator, any physical or mental condition that would affect the participation in the study or may interfere with the study procedures, evaluations and outcome assessments.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DREAM OCT; All 50 patients will have both eyes (if able) imaged, 3 times, on the same day during their clinic visit.	Device: DREAM OCT; Swept Source OCT (similar to Zeiss Plex Elite)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing difference in intraocular structures	Assessing the performance of the DREAM VG OCT scan patterns in high myopes including glaucomatous eyes to see if there are differences in the lamina cribrosa structure when compared to patients previous Cirrus OCTs.	Baseline
Assessing difference in intraocular vascular structures	Assessing differences in vascular density in areas with presumed myopic-related field defects vs. low tension glaucoma perimetric disease	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing repeatability of scans	Analyze the repeatability of quantitative RNFL and GCC parameters.	Baseline

Collaborators and Investigators

• Sponsor: Robert T. Chang, MD
• Investigators: Principal Investigator: Robert Chang, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases
• Other Study ID Numbers: 70411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes