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

Completed

• Conditions: Healthy Eyes; Retinal Disease
• Interventions: Device: SPECTRALIS; Device: SPECTRALIS with Flex Module

• Registration Number: NCT04661124
• Lead Sponsor: Heidelberg Engineering GmbH

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-03
• Study Start: 2020-12-10
• Study First Posted: 2020-12-10
• Primary Completion: 2021-09-17
• Study Completion: 2024-04-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult Pathology Eyes	SPECTRALIS	see Inclusion/Exclusion criteria; imaged with OCT and/or OCTA
Adult Normal Eyes	SPECTRALIS	see Inclusion/Exclusion criteria; imaged with OCT and/or OCTA
Adult Normal Eyes	SPECTRALIS with Flex Module	see Inclusion/Exclusion criteria; imaged with OCT and/or OCTA
Adult Pathology Eyes	SPECTRALIS with Flex Module	see Inclusion/Exclusion criteria; imaged with OCT and/or OCTA

Primary Outcome Measures

Name	Time	Method
Agreement in identification of abnormalities of the acquired Standard OCT images between the devices	through study completion, average of 1 day	based on pre-specified abnormalities
Agreement in identification of abnormalities of the acquired OCTA images between the devices	through study completion, average of 1 day	based on pre-specified abnormalities
The image quality grade of the acquired images as determined by an independent reading center	through study completion, average of 1 day	OCT, OCTA and IR cSLO - graded Good (2)/Average (1)/Poor (0)

Secondary Outcome Measures

Name	Time	Method
Adverse events	through study completion, average of 1 day	All AEs

Trial Locations

Locations (1)

Duke Eye Center; 🇺🇸 Durham, North Carolina, United States