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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05876689
Other study ID # 70411
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 9, 2023
Est. completion date December 2024

Study information

Verified date November 2023
Source Stanford University
Contact Study Team
Phone 6504975942
Email zacwenn@stanford.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
DREAM OCT
Swept Source OCT (similar to Zeiss Plex Elite)

Locations

Country Name City State
United States Byers Eye Institute Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Robert T. Chang, MD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Assessing repeatability of scans Analyze the repeatability of quantitative RNFL and GCC parameters. Baseline
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