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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04661124

Enrollment

Registered

2020-12-10

Start date

2020-12-10

Completion date

2024-04-22

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Eyes, Retinal Disease

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.

Interventions

DEVICESPECTRALIS

ophthalmic imaging device with head and chinrest

DEVICESPECTRALIS with Flex Module

ophthalmic imaging device on mobile instrumentation stand

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
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)
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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026