NCT03921931 Retinal Photoreceptor Outer Segment Length Before and After Light Stimulation - a Pilot Study
| NCT ID | NCT03921931 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Macular Degeneration, Dry |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2018-11-26 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2018-11-26 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
It has been shown that reactions of human retinal photoreceptors to a light stimulus can be measured with custom-made, research prototype optical coherence tomography (OCT) systems. This can be used as a biomarker for the function of the photoreceptors. Due to the high technical demands on the system, however, the technique is currently not available for clinical purposes. In this pilot study a protocol to measure changes in retinal photoreceptor layer thickness before and after light stimulation shall be developed based on a commercial OCT system and newly developed algorithms. Other variables, such as circadian processes shall be investigated as well. After measurements in healthy volunteers, the protocol is planned to be applied in patients with primary open angle glaucoma (POAG) and age-related macular degeneration (AMD) to test for feasibility of the method in these patient groups.
Eligibility Criteria
Inclusion Criteria: * men and women aged over 18 years * signed informed consent form * ametropia below 3 diopters * ability and willingness to follow instructions for healthy volunteers: * normal ophthalmologic findings for primary open angle glaucoma patients (POAG): * diagnosed POAG * MD \<= 10 dB for age-related macular degeneration (AMD): * diagnosed dry AMD * diagnosed stage II or stage III AMD Exclusion Criteria: * Presence of any abnormalities preventing reliable measurements * Ocular inflammation and ocular disease interfering with the study aims * Use of photosensitizing medication (phototoxic drugs, photoallergic drugs) in the 3 months preceding the study * Presence of any condition with the possibility of causing photosensitivity, including systemic lupus erythematosus SLE, Porphyria, Vitiligo, Xeroderma Pigmentosum and Albinism * Presence of any form of epilepsy * Ocular surgery in the 3 months preceding the study * Pregnancy, planned pregnancy or lactating * Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease
Contact & Investigator
Doreen Schmidl, MD,PhD
PRINCIPAL INVESTIGATOR
Department of Clinical Pharmacology, Medical University of Vienna
Frequently Asked Questions
Who can join the NCT03921931 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Macular Degeneration, Dry. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03921931 currently recruiting?
Yes, NCT03921931 is actively recruiting participants. Contact the research team at doreen.schmidl@meduniwien.ac.at for enrollment information.
Where is the NCT03921931 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT03921931 clinical trial?
NCT03921931 is sponsored by Medical University of Vienna. The principal investigator is Doreen Schmidl, MD,PhD at Department of Clinical Pharmacology, Medical University of Vienna. The trial plans to enroll 35 participants.