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

NCT04661124 | Completed FDA Device

• 1 other identifier: S-2018-3
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinal Disease; Healthy Eyes

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Adverse events

  through study completion, average of 1 day

Study Arms (2)

Adult Normal Eyes

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

Device: SPECTRALIS; Device: SPECTRALIS with Flex Module

Adult Pathology Eyes

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

Device: SPECTRALIS; Device: SPECTRALIS with Flex Module

Interventions

SPECTRALIS DEVICE

ophthalmic imaging device with head and chinrest

Also known as: SPECTRALIS HRA+OCT (and variants) with OCT Angiography Module

Adult Normal Eyes; Adult Pathology Eyes

SPECTRALIS with Flex Module DEVICE

ophthalmic imaging device on mobile instrumentation stand

Also known as: SPECTRALIS HRA+OCT (and variants) with Flex Module

Adult Normal Eyes; Adult Pathology Eyes

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age ≥ 22 years
• Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
• Physically able to be positioned in all required imaging positions (upright at chinrest and supine).
• Able to fixate.
• Best corrected visual acuity ≥ 20/40 in both eyes.

You may not qualify if:

• Eye with ocular media not sufficiently clear to obtain acceptable study-related imaging.
• Subjects who cannot tolerate the imaging procedures.
• Clinically significant ocular disease in either eye as determined by an Investigator.
• Ocular surgical intervention (except for refractive laser surgery or cataract surgery) in either eye.
• Adult Posterior Segment Abnormality Eye Population (AD)
• Age ≥ 22 years
• Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
• Physically able to be positioned in all required imaging positions (upright at chinrest and supine).
• Able to fixate.
• Eye with a structural and vascular posterior segment abnormality due to ocular disease and/or trauma.
• Eye with ocular media not sufficiently clear to obtain acceptable study-related imaging.
• Subjects who cannot tolerate the imaging procedures.

Sponsors & Collaborators

• Heidelberg Engineering GmbH: lead
• Duke University: collaborator

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Lejla Vajzovic, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Study Start: December 10, 2020
• Primary Completion: September 17, 2021
• Study Completion: April 22, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)