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
1 other identifier
interventional
35
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 26, 2018
CompletedFirst Submitted
Initial submission to the registry
April 4, 2019
CompletedFirst Posted
Study publicly available on registry
April 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
May 16, 2025
March 1, 2025
7.5 years
April 4, 2019
May 13, 2025
Conditions
Keywords
Outcome Measures
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
1 day
Secondary Outcomes (3)
Light stimulation of contralateral eye
1 day
Difference in photoreceptor layer thickness over the course of 8 hours
8 hours
En face maps
1 day
Study Arms (3)
healthy volunteers
EXPERIMENTALlight stimulation
primary open angle glaucoma patients
EXPERIMENTALlight stimulation
age-related macular degeneration patients
EXPERIMENTALlight stimulation
Interventions
Stimulation of the retina with white light
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Vienna, 1090, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Doreen Schmidl, MD,PhD
Department of Clinical Pharmacology, Medical University of Vienna
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, MD, PhD
Study Record Dates
First Submitted
April 4, 2019
First Posted
April 19, 2019
Study Start
November 26, 2018
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
May 16, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share