Macular Degeneration, DryNCT03921931
Retinal Photoreceptor Outer Segment Length Before and After Light Stimulation - a Pilot Study
A study testing White light stimulation in people with Macular Degeneration, Dry and Primary Open-angle Glaucoma, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration, Dry, Primary Open-angle Glaucoma
- What is being tested?
- White light stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteAustria
- Study dates
- 26 Nov 2018to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, State of Vienna, 1090
Doreen Schmidl, MD, PhD, 0043140400 ext. 29810, doreen.schmidl@meduniwien.ac.at
Doreen Schmidl, MD, PhD
About this study
Official title: Assessment of Retinal Photoreceptor Outer Segment Length With Optical Coherence Tomography Before and After Light Stimulation - a Pilot Study
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.
- Being tested
- White light stimulation
- Keywords
- light stimulation, retinal photoreceptors, light adaptation, functional optical coherence tomography, optophysiology, intrinsic optical signals
- Medical subject headings
- Geographic Atrophy, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White light stimulationOther
Stimulation of the retina with white light
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Experimental | light stimulation Receives: Other: White light stimulation |
| primary open angle glaucoma patients | Experimental | light stimulation Receives: Other: White light stimulation |
| age-related macular degeneration patients | Experimental | light stimulation Receives: Other: White light stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (3)
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
Measured: 1 day
Difference in photoreceptor layer thickness over the course of 8 hours
Influence of circadian rhythm on the length of retinal photoreceptor outer segments
Measured: 8 hours
En face maps
test an algorithm for production of en face maps of retinal photoreceptor outer segment length
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start26 Nov 2018
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Degeneration, DryStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doreen Schmidl, Medical University of Vienna
- Investigators
- Doreen Schmidl, MD,PhD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921931
- Sponsor's protocol ID
- OPHT-050418
- Status last verified
- Mar 2025
- First submitted
- 4 Apr 2019
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Retinal Photoreceptor Outer Segment Length With Optical Coherence Tomography Before and After Light Stimulation - a Pilot Study
- ClinicalTrials.gov ID
- NCT03921931
- Acronym / sponsor ID
- OPHT-050418
- Keywords
- light stimulation, retinal photoreceptors, light adaptation, functional optical coherence tomography, optophysiology, intrinsic optical signals
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Experimental | Other: White light stimulationlight stimulation |
| primary open angle glaucoma patients | Experimental | Other: White light stimulationlight stimulation |
| age-related macular degeneration patients | Experimental | Other: White light stimulationlight stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- men and women aged over 18 years
- signed informed consent form
- ametropia below 3 diopters
- ability and willingness to follow instructions
- normal ophthalmologic findings
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White light stimulationStimulation of the retina with white light | Other | age-related macular degeneration patients, healthy volunteers, primary open angle glaucoma patients |
Primary outcome
Light stimulation
Time frame: 1 day
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
3 secondary outcomes
Light stimulation of contralateral eye
Time frame: 1 day
Difference in photoreceptor layer thickness over the course of 8 hours
Time frame: 8 hours
En face maps
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Doreen Schmidl, MD,PhD principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White light stimulation in people with Macular Degeneration, Dry and Primary Open-angle Glaucoma, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doreen Schmidl, MD,PhD (0043140400 ext. 29810, doreen.schmidl@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Light stimulation (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.