Imaging of Vitreous Opacities in a Canadian Population

Floaters Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06204848
• Other study ID #: SVO-IDFIH002
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: November 2024

Study information

• Verified date: April 2024
• Source: PulseMedica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Floaters

Intervention

Device:
• SVO-ID
Combined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for imaging of the eye

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
PulseMedica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful capture of SLO and OCT imaging data of SVOs for algorithm development	Successful collection of SLO and OCT imaging data	Through study completion, an average of 6-8 months
Secondary	Collection of patient-reported symptoms	Patient feedback regarding symptoms related to SVOs being imaged	Through study completion, an average of 6-8 months