Retinal Photoreceptor Outer Segment Length Before and After Light Stimulation - a Pilot Study (NCT03921931) | Clinical Trial Compass
RecruitingNot Applicable
Retinal Photoreceptor Outer Segment Length Before and After Light Stimulation - a Pilot Study
Austria35 participantsStarted 2018-11-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.