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

NCT ID: NCT03921931

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2026-05-31

Brief Summary

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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

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Conditions

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Macular Degeneration, Dry Primary Open-angle Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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healthy volunteers

light stimulation

Group Type EXPERIMENTAL

White light stimulation

Intervention Type OTHER

Stimulation of the retina with white light

primary open angle glaucoma patients

light stimulation

Group Type EXPERIMENTAL

White light stimulation

Intervention Type OTHER

Stimulation of the retina with white light

age-related macular degeneration patients

light stimulation

Group Type EXPERIMENTAL

White light stimulation

Intervention Type OTHER

Stimulation of the retina with white light

Interventions

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White light stimulation

Stimulation of the retina with white light

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Doreen Schmidl

Associate Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Doreen Schmidl, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

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Medical University of Vienna, Department of Clinical Pharmacology

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Doreen Schmidl, MD,PhD

Role: CONTACT

0043140400 ext. 29810

Facility Contacts

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Doreen Schmidl, MD, PhD

Role: primary

0043140400 ext. 29810

Other Identifiers

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OPHT-050418

Identifier Type: -

Identifier Source: org_study_id

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