Swept Source OCT Imaging With the DREAM VG-OCT

• Sponsor: Robert T. Chang, MD (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05876689
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 9.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Diseases; Myopia; Glaucoma	Device: DREAM OCT

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Swept Source OCT Imaging With the DREAM VG-OCT
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. Assessing difference in intraocular structures [Baseline]

   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.

2. Assessing difference in intraocular vascular structures [Baseline]

   Assessing differences in vascular density in areas with presumed myopic-related field defects vs. low tension glaucoma perimetric disease

Secondary Outcome Measures

1. Assessing repeatability of scans [Baseline]

   Analyze the repeatability of quantitative RNFL and GCC parameters.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Age greater than or equal to 18

• Myopes with 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Byers Eye Institute	Palo Alto	California	United States	94303

Sponsors and Collaborators

• Robert T. Chang, MD

Investigators

• Principal Investigator: Robert Chang, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robert T. Chang, MD, Associate Professor of Ophthalmology, Stanford University
• ClinicalTrials.gov Identifier: NCT05876689
• Other Study ID Numbers: 70411
• First Posted: May 25, 2023
• Last Update Posted: May 25, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Eye Diseases

Study Results

No Results Posted as of May 25, 2023