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Imaging of Vitreous Opacities in Human Eyes

Sponsor
PulseMedica (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06097897
Collaborator
(none)
150
Enrollment
1
Location
1
Arm
6
Anticipated Duration (Months)
24.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SVO-ID
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of a Non-Invasive Imaging Device for the Acquisition of Imaging Data of Vitreous Opacities in Human Eyes
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Successful capture of SLO and OCT imaging data of SVOs for algorithm development [Through study completion, an average of 6 months]

    Successful collection of SLO and OCT imaging data

Secondary Outcome Measures

  1. Collection of patient-reported symptoms [Through study completion, an average of 6 months]

    Patient feedback regarding symptoms related to SVOs being imaged

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Male or female

  • 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:

  • Individuals under 18 years of age

  • Presence of active bleeding in the retina

  • Cataract Grade 3 and above

  • Opacification of lens or cornea, lens, or vitreous (that would preclude clear imaging by the SVO-ID)

  • Principal Investigator's determination that the subject is not suitable

Contacts and Locations

Locations

Site City State Country Postal Code
1 Panama Eye Center Panama city Panama

Sponsors and Collaborators

  • PulseMedica

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PulseMedica
ClinicalTrials.gov Identifier:
NCT06097897
Other Study ID Numbers:
  • SVO-IDFIH001
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 24, 2023