The Heidelberg Engineering ANTERION Imaging Agreement Study

Heidelberg Engineering

Status: Completed

Conditions: Normal Eyes; Eye Abnormalities

Treatments: Device: ANTERION

Study type: Observational

Funder types: Industry

Identifiers

NCT04068818

B-2018-4

Details and patient eligibility

About

This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess image quality of acquired biometry images of the eye

Full description

The conducted study is a non-interventional study for an imaging device used in the aid of ophthalmology diagnosis. Because the study is not interventional, the study is not an Applicable Clinical Trial per Clinicaltrials.gov definition.

Enrollment: 87 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 22 years or older
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
3. Able to fixate
4. With eye pathology status for each of the two eye populations. A. Eye with normal anterior segment

B. Eyes with anterior segment abnormalities identified with the slit lamp exam including but not limited to:

• glaucoma surgeries: trabeculectomy, laser peripheral iridotomy and drainage devices
• corneal surgeries: corneal inlays and corneal transplants
• pterygium and corneal scar

Exclusion criteria

1. Subjects which were enrolled in the B-2018-1 Study
2. Physical inability to be properly positioned at the study devices or eye exam equipment
3. Contact lenses worn during imaging

Trial design

87 participants in 2 patient groups

Eyes with normal anterior segment

Treatment:

Device: ANTERION

Eyes with anterior segment abnormalities

Treatment:

Device: ANTERION