Retinal Photoreceptor Outer Segment Length Before and After Light Stimulation - a Pilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Vienna
About this trial
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
This trial accepts healthy volunteersQualifiers
men and women aged over 18 years
signed informed consent form
ametropia below 3 diopters
ability and willingness to follow instructions
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
White light stimulation
Other interventionStimulation of the retina with white light
Treatment groups
35 Participants
are divided into 3 treatment groupsGroup A: healthy volunteersExperimental treatment 1 intervention
Group B: primary open angle glaucoma patientsExperimental treatment 1 intervention
Group C: age-related macular degeneration patientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Light stimulation
Optical path length changes between inner segment outer segment junction and retinal pigment epithelium (RPE) will be measured with OCT in 15 healthy volunteers, 10 POAG patients and 10 AMD patients before and after light stimulation
Time frame
1 daySecondary outcomes
1
Light stimulation of contralateral eye
Optical path length changes between inner segment outer segment junction and retinal pigment epithelium (RPE) will be measured with OCT in 15 healthy volunteers, 10 POAG patients and 10 AMD patients before and after light stimulation in the contralateral eye
Time frame
1 day2
Difference in photoreceptor layer thickness over the course of 8 hours
Influence of circadian rhythm on the length of retinal photoreceptor outer segments
Time frame
8 hours3
En face maps
test an algorithm for production of en face maps of retinal photoreceptor outer segment length
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov