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NCT03921931Recruiting

Retinal Photoreceptor Outer Segment Length Before and After Light Stimulation - a Pilot Study

Assessment of Retinal Photoreceptor Outer Segment Length With Optical Coherence Tomography Before and After Light Stimulation - a Pilot Study

Source: ClinicalTrials.gov · Last updated 16 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
35 (estimated)
First submitted
4 Apr 2019
Start date
26 Nov 2018
Primary completion date
31 May 2026
Lead sponsor
Medical University of Vienna
NCT number
NCT03921931

What you commit to

  • Study type: Interventional
  • Planned participants: 35
  • From 26 Nov 2018 to the primary completion date, 31 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of photosensitizing medication (phototoxic drugs, photoallergic drugs) in the 3 months preceding the study
  • Ocular surgery in the 3 months preceding the study

Other illness

  • Ocular inflammation and ocular disease interfering with the study aims
  • 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
  • Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease

Other

  • Presence of any abnormalities preventing reliable measurements
  • Pregnancy, planned pregnancy or lactating

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Vienna, Department of Clinical Pharmacology
Coordinator of this site? Confirm its status
ViennaAustriaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.