Clinical trial NCT04661124: Evaluation of the Heidelberg Engineering SPECTRALIS with Flex Module for In-vivo Imaging in the Supine Position
Official title: Evaluation of the Heidelberg Engineering SPECTRALIS with Flex Module for In-vivo Imaging in the Supine Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Disease
Healthy Eyes
Lead sponsor: Heidelberg Engineering GmbH
Sponsor class: INDUSTRY
Collaborators: name: Duke University
First posted: 2020-12-10
Enrollment: 88
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with healthy eyes (AN), and adults with structural and vascular retinal abnormalities (AD)

Brief summary: This is a prospective clinical study conducted at one clinical site in the United States.

Detailed description: The conducted study is an observational study for an imaging device used in the aid of ophthalmology diagnosis.

Eligibility criteria: Adult Normal Eyes Population (AN)

Inclusion Criteria for AN Population

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. Best corrected visual acuity ≥ 20/40 in both eyes.

Exclusion Criteria for AN Population

1. Eye with ocular media not sufficiently clear to obtain acceptable study-related imaging.
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)

Inclusion Criteria for AD Population

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 for AD Population

1. Eye with ocular media not sufficiently clear to obtain acceptable study-related imaging.
2. Subjects who cannot tolerate the imaging procedures.

Primary outcomes:
measure: The image quality grade of the acquired images as determined by an independent reading center
timeFrame: through study completion, average of 1 day
measure: Agreement in identification of abnormalities of the acquired Standard OCT images between the devices
timeFrame: through study completion, average of 1 day
measure: Agreement in identification of abnormalities of the acquired OCTA images between the devices
timeFrame: through study completion, average of 1 day
Secondary outcomes:
measure: Adverse events
timeFrame: through study completion, average of 1 day
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Lejla Vajzovic, MD
role: PRINCIPAL_INVESTIGATOR
References: