NCT06097897

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2025

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

12 months

First QC Date

September 26, 2023

Last Update Submit

April 4, 2025

Conditions

FloatersVitreous Opacities

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Collection of patient-reported symptoms

    Through study completion, an average of one year

Study Arms (1)

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

SVO-IDDEVICE

Combined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for imaging of the eye

Imaging using the SVO-ID

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Panama Eye Center

Panama City, Panama

Location

MeSH Terms

Conditions

vitreous floaters

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 24, 2023

Study Start

April 1, 2024

Primary Completion

March 18, 2025

Study Completion

March 18, 2025

Last Updated

April 8, 2025

Record last verified: 2025-04

Locations

PA(1)