Reproducibility of Blood Flowmetry in Human Retina Using the Nidek Laser Speckle Flowgraphy LSFG-NAVI System

NCT04014933 | Completed

• 1 other identifier: LSFG Repro
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

In addition to intraocular pressure blood perfusion pressure in the optic nerve is an important factor determing the cause of glaucoma. Increasing evidence suggests that in glaucoma patients retinal blood may be decreased.

Conditions

Open Angle Glaucoma; Normal Tension Glaucoma; Healthy

Keywords

glaucoma; retinal blood flow; ocular perfusion pressure

Outcome Measures

Primary Outcomes (2)

• Coefficients of variation (COV)

  COVs from 3 measurements of ocular blood flow at visit 1 of observer 1 and at visit 1 of observer 1 and from observer 2 will be computed.

  1 month

• intraclass correlation coefficients (ICCs)

  Intraobserver ICC, interobserver ICC, and inter-session ICC will be computed

  1 month

Secondary Outcomes (4)

• Cofounder

  1 month

• Cofounder

  1 month

• Cofounder

  1 month

• Cofounder

  1 month

Study Arms (3)

open-angle glaucoma

patients with a diagnosis of open-angle glaucoma, i.e. untreated IOP \>21mmHg plus glaucomatous disc changes and/or visual field defects typical for glaucoma

Diagnostic Test: LASER SPECKLE FLOWGRAPHY

normal tension glaucoma

patients with a diagnosis of normal tension glaucoma, i.e. untreated IOP \</=21mmHg plus glaucomatous disc changes and/or visual field defects typical for glaucoma

Diagnostic Test: LASER SPECKLE FLOWGRAPHY

healthy controls

individuals with normal optic disc and IOP \</21mmHg and normal visual fields

Diagnostic Test: LASER SPECKLE FLOWGRAPHY

Interventions

LASER SPECKLE FLOWGRAPHY DIAGNOSTIC_TEST

Non-invasive, real-time imaging and measurement of ocular blood flow of the optic disc and peripapillary region

healthy controls; normal tension glaucoma; open-angle glaucoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

3 groups as described above will be recruted from the outpatient department of the Ophthalmology Department at the UniversityHospital Zurich, Zurich, Switzerland and the Ophthalmology Department at the Cantonal Hospital Aarau, Aarau, Switzerland

You may qualify if:

• signed Patient Informed Consent form
• Be at least 18 years old
• Diagnosis of primary or secondary open-angle glaucoma or normal tension glaucoma or healthy controls

You may not qualify if:

• Age \< 18 years
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
• No vulnerable participants will be included in this study.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Ophthalmology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Low Tension Glaucoma; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Study Officials

• Marc Töteberg-Harms, MD, FEBO

  UniversityHospital Zurich, Department of Ophthalmology, Zurich, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 10, 2019
• Study Start: July 1, 2019
• Primary Completion: February 9, 2021
• Study Completion: December 31, 2021
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)