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

• ClinicalTrials.gov Identifier: NCT03921931
• Recruitment Status: Recruiting
• First Posted: April 19, 2019
• Last Update Posted: February 24, 2021
• Sponsor: Medical University of Vienna
• Information provided by (Responsible Party): Doreen Schmidl, Medical University of Vienna

Tracking Information

• First Submitted Date: April 4, 2019
• First Posted Date: April 19, 2019
• Last Update Posted Date: February 24, 2021
• Actual Study Start Date: November 26, 2018
• Estimated Primary Completion Date: May 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science

Condition

• Macular Degeneration, Dry
• Primary Open-angle Glaucoma

Intervention

Other: White light stimulation

Stimulation of the retina with white light

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 17, 2019): 35
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 31, 2021
• Estimated Primary Completion Date: May 31, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT03921931
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Doreen Schmidl, Medical University of Vienna
• Study Sponsor: Medical University of Vienna
• Collaborators: Not Provided

Investigators

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

• PRS Account: Medical University of Vienna
• Verification Date: February 2021