Evaluation of the Repeatability and Reproducibility of OCTA Image Quality With the Heidelberg Engineering SPECTRALIS With OCT Angiography Module
Terminated
- Conditions
- Normal EyesRetinal Vascular
- Interventions
- Device: OCT AngiographyDevice: Color Fundus PhotographyDevice: Optical Coherence Tomography
- Registration Number
- NCT03530449
- Lead Sponsor
- Heidelberg Engineering GmbH
- Brief Summary
Repeatability and Reproducibility of OCTA Image Quality with the Heidelberg Engineering SPECTRALIS
- Detailed Description
The objectives of this study are to:
1. Assess the repeatability and reproducibility of the SPECTRALIS with OCTA Module image quality
2. Assess the repeatability and reproducibility of visibility of key anatomical vascular structures in the SPECTRALIS with OCTA Module
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 39
Inclusion Criteria
- All subjects: Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
- Age ≥ 22
Subjects with Normal Eyes:
- Corrected visual acuity ≥ 20/40 in each eye
Subjects with Pathology:
- Subjects with vascular retinal conditions in at least one eye
- Subjects included should have a range of retinal vascular pathologies likely to appear in OCTA imaging, 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 Criteria
- All Subjects:
- 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 contraindication to pupillary dilation in the study eye
- Subjects with Normal Eyes:
- Subjects with uncontrolled systemic conditions, or ocular disease, as determined by the Investigator, during the eye exam and CFP
- History of ocular surgical intervention (except for refractive or cataract surgery) in either eye
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects with Normal Eyes OCT Angiography Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects without ophthalmic pathology Subjects with Normal Eyes Optical Coherence Tomography Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects without ophthalmic pathology Subjects with Retinal Vascular Pathology Color Fundus Photography Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects with retinal vascular ophthalmic pathology Subjects with Normal Eyes Color Fundus Photography Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects without ophthalmic pathology Subjects with Retinal Vascular Pathology Optical Coherence Tomography Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects with retinal vascular ophthalmic pathology Subjects with Retinal Vascular Pathology OCT Angiography Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects with retinal vascular ophthalmic pathology
- Primary Outcome Measures
Name Time Method OCTA image quality day 1 Image quality grading results of study selected images
Visualization of key anatomical vascular structures on OCTA day 1 Grading of visibility of key anatomical vascular structures of study selected images
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
State University of New York College of Optometry (SUNY)
🇺🇸New York, New York, United States