MHz-OCT

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00005173

Enrollment

Registered

2013-07-26

Start date

2013-09-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

H30-H36

Interventions

Group 1: In patients, who are imaged by standard OCT for retinal changes, additionally MHz OCT is applied. Group 2: Current generation standard OCT

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Patients can be included, who need for diagnosis or follow-up a standard OCT • Men and women >18 years • Informed written consent

Exclusion criteria

Exclusion criteria: General: • No written informed consent; • age<18 years; • pregnancy of breast feeding; • patients with severely reduced health status; • patients unable to comply and in whom conventional OCT cannot be performed; • neurologic disease within the face/affecting the eye (e. g. facial palsy); • allergy against Polymethylmethacrylate (PMMA); Concomitant eye disease: • active inflammation and infections of the eye; • uncontrolled glaucoma; Previous therapies of the eye (e.g. laser or surgery) are no exclusion criteria.

Design outcomes

Secondary

Measure	Time frame
Sekundary outcomes are the effects of different recording and analysis protocols with MHz OCT for different diseases. Also as an explantory endpoint, potential requirements for the usability of the device are investigated.	—

Primary

Measure	Time frame
Primary endpoint is based on the comparison of OCT images, which are obtained by image analysis from MHz-OCT datasets, with OCT images from current generation OCT systems (e.g. Heidelberg Spectralis SD-OCT). The question to be answered is, if diagnostic quality of images from the fast 3D MHz-data set are equal or better than current standard SD-OCT technology for diseases of the vitreoretinal interface, within the retina and the choroid. Primary endpoint is defined as no difference in diagnostic clinical quality grading (Grading of "clinical diagnostic value") between MHz-OCT and standard OCT.	—

Measure

Time frame

Primary endpoint is based on the comparison of OCT images, which are obtained by image analysis from MHz-OCT datasets, with OCT images from current generation OCT systems (e.g. Heidelberg Spectralis SD-OCT). The question to be answered is, if diagnostic quality of images from the fast 3D MHz-data set are equal or better than current standard SD-OCT technology for diseases of the vitreoretinal interface, within the retina and the choroid. Primary endpoint is defined as no difference in diagnostic clinical quality grading (Grading of "clinical diagnostic value") between MHz-OCT and standard OCT.

—

Countries

Germany

Contacts

Public ContactMarcus Kernt

Augenklinik der Ludwig-Maximilians Universität

marcus.kernt@med.uni-muenchen.de089-5160-3811

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026