Swept Source OCT Imaging With the DREAM VG-OCT

NCT05876689 | Completed FDA Device

• 1 other identifier: 70411
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eye Diseases; Myopia; Glaucoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Assessing repeatability of scans

  Baseline

Study Arms (1)

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

Interventions

DREAM OCT DEVICE

Swept Source OCT (similar to Zeiss Plex Elite)

DREAM OCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Robert T. Chang, MD: lead

Study Sites (1)

Byers Eye Institute

Palo Alto, California, 94303, United States

Location

MeSH Terms

Conditions

Eye Diseases; Myopia; Glaucoma

Condition Hierarchy (Ancestors)

Refractive Errors; Ocular Hypertension

Study Officials

• Robert Chang, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 25, 2023
• Study Start: October 9, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)