Measuring retinal photoreceptor response to light stimulation
Assessment of Retinal Photoreceptor Outer Segment Length With Optical Coherence Tomography Before and After Light Stimulation - a Pilot Study
This study is testing a new way to measure how light affects the eye's photoreceptors in healthy people and those with glaucoma or age-related macular degeneration to see if it can help track eye health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT03921931 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to develop a protocol for measuring changes in retinal photoreceptor layer thickness using a commercial optical coherence tomography (OCT) system before and after light stimulation. The study will investigate the feasibility of this method in healthy volunteers and patients with primary open-angle glaucoma and age-related macular degeneration. The research will also explore the influence of circadian processes on retinal responses. By utilizing newly developed algorithms, the study seeks to establish a reliable biomarker for photoreceptor function.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with diagnosed primary open-angle glaucoma or dry age-related macular degeneration.
Not a fit: Patients with ocular abnormalities, inflammation, or those on photosensitizing medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new method for assessing retinal health and function in patients with macular degeneration and glaucoma.
How similar studies have performed: While this approach is innovative, similar studies using optical coherence tomography have shown promise in assessing retinal conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna, State of Vienna
- Medical University of Vienna, Department of Clinical Pharmacology — Vienna, State of Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Doreen Schmidl, MD,PhD — Department of Clinical Pharmacology, Medical University of Vienna
- Study coordinator: Doreen Schmidl, MD,PhD
- Email: doreen.schmidl@meduniwien.ac.at
- Phone: 0043140400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.