Healthy Clinical Trial
— LSFG ReproOfficial title:
Prospective, Non-randomised, Non-controlled Study of Reproducibility of Blood Flowmetry in Human Retina Using the Nidek Laser Speckle Flowgraphy LSFG-NAVI System
NCT number | NCT04014933 |
Other study ID # | LSFG Repro |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2019 |
Est. completion date | December 31, 2021 |
Verified date | June 2023 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | December 31, 2021 |
Est. primary completion date | February 9, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Ophthalmology | Zurich | ZH |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | intraclass correlation coefficients (ICCs) | Intraobserver ICC, interobserver ICC, and inter-session ICC will be computed | 1 month | |
Secondary | Cofounder | Blood pressure will be checked as potential cofounder | 1 month | |
Secondary | Cofounder | heart rate will be checked as potential cofounder | 1 month | |
Secondary | Cofounder | spherical equivalent will be checked as potential cofounder | 1 month | |
Secondary | Cofounder | intraocular pressure will be checked as potential cofounder | 1 month |
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