Imaging of Vitreous Opacities in Human Eyes

Floaters Clinical Trial

Official title:

Evaluation of a Non-Invasive Imaging Device for the Acquisition of Imaging Data of Vitreous Opacities in Human Eyes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06097897
• Other study ID #: SVO-IDFIH001
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: PulseMedica
• Contact: Study Coordinator
• Phone: +1-507-269-7475
• Email: info[@]panamaeyecenter.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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
Panama	Panama Eye Center	Panamá

Sponsors (1)

Lead Sponsor	Collaborator
PulseMedica

Country where clinical trial is conducted

Panama, 

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 months
Secondary	Collection of patient-reported symptoms	Patient feedback regarding symptoms related to SVOs being imaged	Through study completion, an average of 6 months