Imaging of Vitreous Opacities in a Canadian Population

April 1, 2024 updated by: PulseMedica

Acquisition of Imaging Data of Vitreous Opacities in Human Eyes Using a Non-Invasive Imaging Device

The goal of this clinical trial is to capture imaging data of eye floaters in the population to build an imaging database to learn more about them in. Participants will imaged with an investigational ophthalmic imaging device to capture images of their floaters.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Alberta Retina Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 18 years or older
  • Symptomatic vitreous opacities (floaters) in vision
  • Clear ocular media, to allow a clear view of the vitreous for the SVO-ID

Exclusion Criteria:

  • Younger than 18 years of age
  • Presence of vitreous hemorrhage
  • Cataract Grade 3 and above
  • Opacification of lens or cornea, lens, or vitreous
  • Diagnosis of narrow angle glaucoma
  • Refractive error is outside the range of -6D to+3D
  • Astigmatism is outside the range of +/-2D of cylinder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Imaging using the SVO-ID
Patients will have their eyes imaged with the SVO-ID as part of a study visit.
Device: SVO-ID
Combined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for imaging of the eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful capture of SLO and OCT imaging data of SVOs for algorithm development
Time Frame: Through study completion, an average of 6-8 months
Successful collection of SLO and OCT imaging data
Through study completion, an average of 6-8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection of patient-reported symptoms
Time Frame: Through study completion, an average of 6-8 months
Patient feedback regarding symptoms related to SVOs being imaged
Through study completion, an average of 6-8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PulseMedica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

January 3, 2024

First Submitted That Met QC Criteria

January 3, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVO-IDFIH002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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