Holographic OCT for the examination of retinal function

Registry ID
DRKS00040886
Source registry
DRKS
Status
PENDING
Sponsor
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Enrollment
30
Start date
2026-09-01
Completion date
2026-12-31
Last update
2026-08-03

Conditions

Summary

Background Until now, it has not been possible to examine the function of specific areas of the retina, the light-sensitive tissue at the back of the eye, in a detailed and non-invasive manner. In this study, two newly developed imaging systems will be evaluated to determine whether they can provide detailed measurements of retinal function and visualize the smallest blood vessels in the back of the eye. Research question This study aims to investigate whether the two newly developed imaging systems can reliably measure retinal function and visualize the smallest blood vessels in the back of the eye. In addition, the study will assess whether these measurements can be performed reliably in patients with retinal diseases. Furthermore, it will be investigated whether the systems can detect differences between healthy eyes and eyes with retinal diseases. Methods The study will include both healthy volunteers and patients with retinal diseases. Approximately 15 participants will be recruited for each group. Participants will first undergo a standard ophthalmic examination, followed by the examinations using the newly developed imaging systems. Before one of the examinations, participants will spend approximately 20 minutes in a darkened room to allow their eyes to adapt to the dark. The examination will then be repeated several times. Finally, images of the smallest blood vessels in the back of the eye will be acquired several times. In principle, only one eye will be examined. The pupil of the study eye will be dilated before the examination. All examinations are non-contact and painless. The study procedures are completed during a single study visit, and no additional visits are required.

Inclusion criteria

1. subjects/patients with the clear ocular media 2. presence of a signed declaration of consent 3. (for patients): Retinal diseases, including neurodegenerative retinal diseases such as glaucoma.

Exclusion criteria

1. underage or assisted patients 2. patients with relevant media opacities 3. subjects/patients with a narrow chamber angle 4. patients who are assumed to be unable to cooperate with the measurement of the ocular fundus (e.g. pronounced tremor or nystagmus, cognitive disorder) 5. eyes with a corrected visual acuity of less than 0.5 6. eyes with a refractive error larger than +/- 4.0 D. 7. subjects/patients with the oculus unicus

Primary outcomes

Measurability of ORG signals and of choriocapillaris flow defined as the proportion of subjects/examinations in which analyzable signals can be obtained

Locations

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