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

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT03921931
Collaborator
(none)
35
1
3
42.1
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Study Details

Study Description

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
  • Other: White light stimulation
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 26, 2018
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Light stimulation [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 [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 [8 hours]

    Influence of circadian rhythm on the length of retinal photoreceptor outer segments

  3. En face maps [1 day]

    test an algorithm for production of en face maps of retinal photoreceptor outer segment length

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna, Department of Clinical Pharmacology Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Doreen Schmidl, MD,PhD, Department of Clinical Pharmacology, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Doreen Schmidl, Associate Professor, MD, PhD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT03921931
Other Study ID Numbers:
  • OPHT-050418
First Posted:
Apr 19, 2019
Last Update Posted:
Sep 8, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Doreen Schmidl, Associate Professor, MD, PhD, Medical University of Vienna
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2021