Low Cost OCT for Point of Care

Not Applicable

Completed

• Conditions: Optical Coherence Tomography (OCT) of the Retina
• Interventions: Device: OCT imaging

• Registration Number: NCT03323307
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to compare the performance of a prototype optical coherence tomography (OCT) machine with currently available high resolution OCT machines.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-27
• Study Start: 2018-03-28
• Primary Completion: 2018-12-13
• Study Completion: 2018-12-13
• Status Verified: 2019-11
• Results First Submitted: 2019-11-12
• Results First Submitted QC: 2019-11-12
• Last Update Submitted: 2019-11-12
• Results First Posted: 2019-12-05
• Last Update Posted: 2019-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• patients scheduled to receive standard OCT testing as part of their clinical visit

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Exclusion Criteria

• none

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OCT imaging	OCT imaging	OCT device images retina

Primary Outcome Measures

Name	Time	Method
Number of Participants With Acceptable OCT Image Quality	day 1	measured by: ability to see clearly defined and recognizable structures of the retina with the low cost OCT device

Secondary Outcome Measures

Name	Time	Method
Central Macular Thickness	day 1	compare measurements of central macular thickness obtained with low cost OCT system and Heidelberg Spectralis OCT system
Total Macular Volume	day 1	compare total macular volume measurements obtained with low cost OCT system and Heidelberg Spectralis OCT system

Trial Locations

Locations (1)

University of North Carolina Kittner Eye Center; 🇺🇸 Chapel Hill, North Carolina, United States