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Retinal Photoreceptor Outer Segment Length Before and After Light Stimulation - a Pilot Study

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ClinicalTrials.gov Identifier: NCT03921931
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Doreen Schmidl, Medical University of Vienna

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.

Condition or disease Intervention/treatment Phase
Macular Degeneration, Dry Primary Open-angle Glaucoma Other: White light stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessment of Retinal Photoreceptor Outer Segment Length With Optical Coherence Tomography Before and After Light Stimulation - a Pilot Study
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Experimental: healthy volunteers
light stimulation
Other: White light stimulation
Stimulation of the retina with white light

Experimental: primary open angle glaucoma patients
light stimulation
Other: White light stimulation
Stimulation of the retina with white light

Experimental: age-related macular degeneration patients
light stimulation
Other: White light stimulation
Stimulation of the retina with white light




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Light stimulation of contralateral eye [ 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 in the contralateral eye

  2. Difference in photoreceptor layer thickness over the course of 8 hours [ Time Frame: 8 hours ]
    Influence of circadian rhythm on the length of retinal photoreceptor outer segments

  3. En face maps [ Time Frame: 1 day ]
    test an algorithm for production of en face maps of retinal photoreceptor outer segment length



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921931


Contacts
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Contact: Doreen Schmidl, MD,PhD 0043140400 ext 29810 doreen.schmidl@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna, Department of Clinical Pharmacology Recruiting
Vienna, Austria, 1090
Contact: Doreen Schmidl, MD, PhD    0043140400 ext 29810    doreen.schmidl@meduniwien.ac.at   
Principal Investigator: Doreen Schmidl, MD, PhD         
Sub-Investigator: Alina Messner, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Doreen Schmidl, MD,PhD Department of Clinical Pharmacology, Medical University of Vienna

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Responsible Party: Doreen Schmidl, Associate Professor, MD, PhD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03921931     History of Changes
Other Study ID Numbers: OPHT-050418
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Doreen Schmidl, Medical University of Vienna:
light stimulation
retinal photoreceptors
light adaptation
functional optical coherence tomography
optophysiology
intrinsic optical signals
Additional relevant MeSH terms:
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Macular Degeneration
Glaucoma, Open-Angle
Geographic Atrophy
Glaucoma
Ocular Hypertension
Eye Diseases
Retinal Degeneration
Retinal Diseases