Evaluation of the Heidelberg Engineering SPECTRALIS With Flex Module for In-vivo Imaging in the Supine Position

Heidelberg Engineering

Status: Completed

Conditions: Retinal Disease; Healthy Eyes

Treatments: Device: SPECTRALIS; Device: SPECTRALIS with Flex Module

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04661124

S-2018-3

Details and patient eligibility

About

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

Full description

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

Enrollment: 88 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

88 participants in 2 patient groups

Adult Normal Eyes

Description:

see Inclusion/Exclusion criteria; imaged with OCT and/or OCTA

Treatment:

Device: SPECTRALIS with Flex Module

Device: SPECTRALIS

Adult Pathology Eyes

Description:

see Inclusion/Exclusion criteria; imaged with OCT and/or OCTA

Treatment:

Device: SPECTRALIS with Flex Module

Device: SPECTRALIS