Imaging of Vitreous Opacities in Human Eyes | NCT06097897

Studies
Imaging of Vitreous Opacities in Human Eyes

NCT06097897

Sponsor

PulseMedica

Status

Completed

Last Update Posted

Apr 8, 2025Actual

Enrollment

91Actual

Phase

Not Applicable

Conditions

Floaters
Vitreous Opacities

Interventions

SVO-ID

Countries

Panama

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Actual

Primary Completion Date

Mar 18, 2025Actual

Completion Date

Mar 18, 2025Actual

First Submitted Date

Sep 26, 2023

First Submission Date that Met QC Criteria

Oct 19, 2023

First Posted Date

Oct 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2025

Last Update Posted Date

Apr 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Vitreous opacities (VOs), commonly known as floaters, are dark spots that appear in, and may float across your vision. Presently, there is a lack of available data in the literature regarding VOs. This study aims to obtain imaging data of VOs in the population to build an imaging database of VOs to learn more about them.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

91Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Imaging using the SVO-ID	Experimental	Patients will have their eyes imaged with the SVO-ID as part of a study visit.	Device: SVO-ID

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SVO-ID	Device	Combined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for imaging of the eye	Imaging using the SVO-ID

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 one year

Secondary Outcomes

Measure	Description	Time Frame
Collection of patient-reported symptoms	Patient feedback regarding symptoms related to SVOs being imaged	Through study completion, an average of one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18 years or older
SVO-related symptoms in vision
Clear ocular media, to allow a clear view of the vitreous for the SVO-ID

Exclusion Criteria:

Presence of vitreous hemorrhage
Cataract Grade 3 and above
Opacification of lens, cornea, 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C000726608	vitreous floaters

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided