Status:
COMPLETED
Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module
Lead Sponsor:
Heidelberg Engineering GmbH
Conditions:
Retinal Vascular
Normal Eyes
Eligibility:
All Genders
22+ years
Brief Summary
Assessment of image quality and clinical relevance of OCT Angiography via comparison to FA/ICGA.
Detailed Description
The objectives of this study are: 1. To compare the OCTA image quality between the SPECTRALIS and the predicate. 2. To compare the agreement of clinical findings on SPECTRALIS OCTA to the predicate.
Eligibility Criteria
Inclusion
- All subjects:
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
- Age ≥ 22
- Subjects with Normal Eyes:
- Subjects presenting at the site without uncontrolled systemic conditions, or ocular disease, as determined by the Investigator
- Corrected visual acuity ≥ 20/40 in each eye
- No history of ocular surgical intervention (except for refractive or cataract surgery) in either eye
- Subjects with Pathology:
- Subjects with retinal conditions in at least one eye.
- Subjects included can have a range of retinal vascular pathologies affecting different anatomic depths through the retina and choroid. Retinal conditions including but not limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and branch or central retinal vein occlusion that give rise to features such as retinal ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization will be included.
Exclusion
- Subjects unable to read or write
- Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging
- Subjects who cannot tolerate the imaging procedures
- Subjects with known allergies to fluorescein dye, Indocyanine Green (ICG), shellfish, drugs for pupillary dilation
- Subjects with contraindication to pupillary dilation in study eye
Key Trial Info
Start Date :
August 23 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 12 2018
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03279939
Start Date
August 23 2017
End Date
January 12 2018
Last Update
September 15 2025
Active Locations (1)
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1
Retina Consultants of Houston
Houston, Texas, United States, 77030