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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

Tracking Information
First Submitted Date  ICMJE April 4, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date April 19, 2019
Actual Study Start Date  ICMJE November 26, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • 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
  • 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
  • En face maps [ Time Frame: 1 day ]
    test an algorithm for production of en face maps of retinal photoreceptor outer segment length
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Retinal Photoreceptor Outer Segment Length Before and After Light Stimulation - a Pilot Study
Official Title  ICMJE Assessment of Retinal Photoreceptor Outer Segment Length With Optical Coherence Tomography Before and After Light Stimulation - a Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Macular Degeneration, Dry
  • Primary Open-angle Glaucoma
Intervention  ICMJE Other: White light stimulation
Stimulation of the retina with white light
Study Arms  ICMJE
  • Experimental: healthy volunteers
    light stimulation
    Intervention: Other: White light stimulation
  • Experimental: primary open angle glaucoma patients
    light stimulation
    Intervention: Other: White light stimulation
  • Experimental: age-related macular degeneration patients
    light stimulation
    Intervention: Other: White light stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2019)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Doreen Schmidl, MD,PhD 0043140400 ext 29810 doreen.schmidl@meduniwien.ac.at
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03921931
Other Study ID Numbers  ICMJE OPHT-050418
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Doreen Schmidl, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Doreen Schmidl, MD,PhD Department of Clinical Pharmacology, Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP