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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03921931
Other study ID # OPHT-050418
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 26, 2018
Est. completion date May 31, 2023

Study information

Verified date March 2023
Source Medical University of Vienna
Contact Doreen Schmidl, MD,PhD
Phone 0043140400
Email doreen.schmidl@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date May 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
White light stimulation
Stimulation of the retina with white light

Locations

Country Name City State
Austria Medical University of Vienna, Department of Clinical Pharmacology Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 day
Secondary 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 1 day
Secondary Difference in photoreceptor layer thickness over the course of 8 hours Influence of circadian rhythm on the length of retinal photoreceptor outer segments 8 hours
Secondary En face maps test an algorithm for production of en face maps of retinal photoreceptor outer segment length 1 day
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