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

Primary Purpose

Macular Degeneration, Dry, Primary Open-angle Glaucoma

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
White light stimulation
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Macular Degeneration, Dry focused on measuring light stimulation, retinal photoreceptors, light adaptation, functional optical coherence tomography, optophysiology, intrinsic optical signals

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University of Vienna, Department of Clinical PharmacologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

healthy volunteers

primary open angle glaucoma patients

age-related macular degeneration patients

Arm Description

light stimulation

light stimulation

light stimulation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Difference in photoreceptor layer thickness over the course of 8 hours
Influence of circadian rhythm on the length of retinal photoreceptor outer segments
En face maps
test an algorithm for production of en face maps of retinal photoreceptor outer segment length

Full Information

First Posted
April 4, 2019
Last Updated
March 14, 2023
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT03921931
Brief Title
Retinal Photoreceptor Outer Segment Length Before and After Light Stimulation - a Pilot Study
Official Title
Assessment of Retinal Photoreceptor Outer Segment Length With Optical Coherence Tomography Before and After Light Stimulation - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Dry, Primary Open-angle Glaucoma
Keywords
light stimulation, retinal photoreceptors, light adaptation, functional optical coherence tomography, optophysiology, intrinsic optical signals

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
healthy volunteers
Arm Type
Experimental
Arm Description
light stimulation
Arm Title
primary open angle glaucoma patients
Arm Type
Experimental
Arm Description
light stimulation
Arm Title
age-related macular degeneration patients
Arm Type
Experimental
Arm Description
light stimulation
Intervention Type
Other
Intervention Name(s)
White light stimulation
Intervention Description
Stimulation of the retina with white light
Primary Outcome Measure Information:
Title
Light stimulation
Description
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
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Light stimulation of contralateral eye
Description
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
Time Frame
1 day
Title
Difference in photoreceptor layer thickness over the course of 8 hours
Description
Influence of circadian rhythm on the length of retinal photoreceptor outer segments
Time Frame
8 hours
Title
En face maps
Description
test an algorithm for production of en face maps of retinal photoreceptor outer segment length
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doreen Schmidl, MD,PhD
Phone
0043140400
Ext
29810
Email
doreen.schmidl@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doreen Schmidl, MD,PhD
Organizational Affiliation
Department of Clinical Pharmacology, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Department of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doreen Schmidl, MD, PhD
Phone
0043140400
Ext
29810
Email
doreen.schmidl@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Doreen Schmidl, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alina Messner, MD

12. IPD Sharing Statement

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

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