Evaluation of the Heidelberg Engineering SPECTRALIS With Flex Module for In-vivo Imaging in the Supine Position
NCT ID: NCT04661124
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
88 participants
OBSERVATIONAL
2020-12-10
2024-04-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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Adult Normal Eyes
see Inclusion/Exclusion criteria; imaged with OCT and/or OCTA
SPECTRALIS
ophthalmic imaging device with head and chinrest
SPECTRALIS with Flex Module
ophthalmic imaging device on mobile instrumentation stand
Adult Pathology Eyes
see Inclusion/Exclusion criteria; imaged with OCT and/or OCTA
SPECTRALIS
ophthalmic imaging device with head and chinrest
SPECTRALIS with Flex Module
ophthalmic imaging device on mobile instrumentation stand
Interventions
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SPECTRALIS
ophthalmic imaging device with head and chinrest
SPECTRALIS with Flex Module
ophthalmic imaging device on mobile instrumentation stand
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
3. Physically able to be positioned in all required imaging positions (upright at chinrest and supine).
4. Able to fixate.
5. Best corrected visual acuity ≥ 20/40 in both eyes.
1. Age ≥ 22 years
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
3. Physically able to be positioned in all required imaging positions (upright at chinrest and supine).
4. Able to fixate.
5. Eye with a structural and vascular posterior segment abnormality due to ocular disease and/or trauma.
Exclusion Criteria
2. Subjects who cannot tolerate the imaging procedures.
3. Clinically significant ocular disease in either eye as determined by an Investigator.
4. Ocular surgical intervention (except for refractive laser surgery or cataract surgery) in either eye.
Adult Posterior Segment Abnormality Eye Population (AD)
1. Eye with ocular media not sufficiently clear to obtain acceptable study-related imaging.
2. Subjects who cannot tolerate the imaging procedures.
22 Years
ALL
Yes
Sponsors
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Duke University
OTHER
Heidelberg Engineering GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Lejla Vajzovic, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke Eye Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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S-2018-3
Identifier Type: -
Identifier Source: org_study_id
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