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

Retinal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04661124
• Other study ID #: S-2018-3
• Status: Active, not recruiting
• Start date: December 10, 2020
• Est. completion date: April 2024

Study information

• Verified date: February 2024
• Source: Heidelberg Engineering GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: April 2024
• Est. primary completion date: September 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Eyes
• Retinal Disease
• Retinal Diseases

Intervention

Device:
• SPECTRALIS
ophthalmic imaging device with head and chinrest
• SPECTRALIS with Flex Module
ophthalmic imaging device on mobile instrumentation stand

Locations

Country	Name	City	State
United States	Duke Eye Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg Engineering GmbH	Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The image quality grade of the acquired images as determined by an independent reading center	OCT, OCTA and IR cSLO - graded Good (2)/Average (1)/Poor (0)	through study completion, average of 1 day
Primary	Agreement in identification of abnormalities of the acquired Standard OCT images between the devices	based on pre-specified abnormalities	through study completion, average of 1 day
Primary	Agreement in identification of abnormalities of the acquired OCTA images between the devices	based on pre-specified abnormalities	through study completion, average of 1 day
Secondary	Adverse events	All AEs	through study completion, average of 1 day