High Resolution Imaging OCT Study

Heidelberg Engineering

Status: Not yet enrolling

Conditions: Age Related Macular Degeneration; Normal Eyes; Eyes With Retinal Diseases; Diabetic Retinopathy

Treatments: Device: OCTA imaging; Device: Autofluorescence Imaging; Device: Infrared reflectance imaging; Device: OCT imaging

Study type: Interventional

Funder types: Industry

Identifiers

NCT07338461

R-2025-1

Details and patient eligibility

About

The goal of this pilot study is to compare image quality between the investigational devices (R1 and HighRes OCT) and the SPECTRALIS (cleared) in adult participants with normal and/or pathology eyes.

Participants will be imaged with different imaging modalities and scan protocols on all study devices.

Enrollment: 97 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All Able and willing to undergo the test procedures, give consent, and to follow instructions.

Signed informed consent Age ≥ 18 years

• Healthy Subjects without uncontrolled systemic conditions, as determined by the investigator Subjects without ocular disease, as determined by the investigator Corrected visual acuity ≥ 20/40 No reported history of ocular surgical intervention (except for refractive or cataract surgery)
• Age-related macular degeneration Subjects with a diagnosis of AMD as determined by the investigator, either early-intermediate, atrophic, or neovascular
• Diabetic retinopathy Subjects with a diagnosis of diabetic retinopathy as determined by the investigator
• Disease with expected altered autofluorescence pattern Subjects with a disease that can be expected to be associated with altered autofluorescence patterns as determined by the investigator

Exclusion criteria

• Subjects unable to read or write
• Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging
• Subjects who cannot tolerate the imaging procedures
• History of photosensitive epilepsy
• Vulnerable subjects, i.e., individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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97 participants in 3 patient groups

Investigational device R1

Experimental group

Description:

Imaging with the investigational device R1

Treatment:

Device: OCT imaging

Device: Infrared reflectance imaging

Device: OCTA imaging

Device: Autofluorescence Imaging

HighRes OCT

Experimental group

Description:

Imaging with the investigational device HighRes OCT

Treatment:

Device: OCT imaging

Device: Infrared reflectance imaging

Device: OCTA imaging

Device: Autofluorescence Imaging

SPECTRALIS

Other group

Description:

Imaging with the approved device SPECTRALIS

Treatment:

Device: OCT imaging

Device: Infrared reflectance imaging

Device: OCTA imaging

Device: Autofluorescence Imaging