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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Retinal Disease; Healthy Eyes
• Intervention / Treatment: Device: SPECTRALIS; Device: SPECTRALIS with Flex Module

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults with healthy eyes (AN), and adults with structural and vascular retinal abnormalities (AD)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult Normal Eyes; see Inclusion/Exclusion criteria; imaged with OCT and/or OCTA	Device: SPECTRALIS; ophthalmic imaging device with head and chinrest; Other Names: SPECTRALIS HRA+OCT (and variants) with OCT Angiography Module; Device: SPECTRALIS with Flex Module; ophthalmic imaging device on mobile instrumentation stand; Other Names: SPECTRALIS HRA+OCT (and variants) with Flex Module
Adult Pathology Eyes; see Inclusion/Exclusion criteria; imaged with OCT and/or OCTA	Device: SPECTRALIS; ophthalmic imaging device with head and chinrest; Other Names: SPECTRALIS HRA+OCT (and variants) with OCT Angiography Module; Device: SPECTRALIS with Flex Module; ophthalmic imaging device on mobile instrumentation stand; Other Names: SPECTRALIS HRA+OCT (and variants) with Flex Module

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	All AEs	through study completion, average of 1 day

Collaborators and Investigators

• Sponsor: Heidelberg Engineering GmbH
• Collaborators: Duke University
• Investigators: Principal Investigator: Lejla Vajzovic, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2020
• Primary Completion (Actual): September 17, 2021
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases
• Other Study ID Numbers: S-2018-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No