Clinical trial NCT03530449: Evaluation of the Repeatability and Reproducibility of OCTA Image Quality With the Heidelberg Engineering SPECTRALIS With OCT Angiography Module
Official title: Evaluation of the Repeatability and Reproducibility of OCTA Image Quality With the Heidelberg Engineering SPECTRALIS With OCT Angiography Module
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Retinal Vascular
Normal Eyes
Lead sponsor: Heidelberg Engineering GmbH
Sponsor class: INDUSTRY
First posted: 2018-05-21
Enrollment: 39
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pathology Population:

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 vascular 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.

Normal Population:

In order to be included in the Normal population, subjects will have to meet all inclusion/exclusion criteria for both eyes. Subjects with a history of ocular surgical interventions will be excluded except for those with refractive and/or cataract surgery.

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

Eligibility criteria: 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

Primary outcomes:
measure: OCTA image quality
timeFrame: day 1
measure: Visualization of key anatomical vascular structures on OCTA
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: State University of New York College of Optometry (SUNY)
state: New York
Study officials:
affiliation: State University of New York College of Optometry
name: Mitchell W Dul, OD
role: PRINCIPAL_INVESTIGATOR
References: