Imaging for Vitreous Floaters

Overseen By Principal Investigator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: PulseMedica

Disqualifiers: Vitreous hemorrhage, Cataract, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather images of eye floaters to better understand them. Participants will have their eyes imaged using a special device called the SVO-ID. The trial seeks individuals who are 18 or older, see floaters in their vision, and have clear eyes for imaging. Those who frequently notice these floaters and meet the criteria may be a good fit for this trial. As an unphased study, this trial offers a unique opportunity to contribute to scientific understanding and potentially improve future treatments for eye floaters.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this imaging device is safe for capturing images of eye floaters?

Research shows that the SVO-ID device takes pictures of eye floaters. Studies have not reported any side effects from this type of imaging. This process resembles taking photos with a camera but uses special equipment for the eyes. Generally, devices like SVO-ID are easy to tolerate because they are non-invasive, meaning nothing enters the body. No specific safety concerns have been reported with SVO-ID, indicating it is safe for imaging eye floaters. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of the SVO-ID imaging technique for vitreous floaters because it offers a novel approach to understanding and potentially managing this condition. Unlike traditional methods that rely on subjective patient feedback, SVO-ID provides detailed imaging of the eye, allowing for a more precise assessment of floaters. This could lead to better-targeted treatments and a clearer understanding of how floaters affect vision. By offering a more objective way to evaluate and track vitreous floaters, this imaging technique may pave the way for new therapies that are more effective and tailored to individual patient needs.

What evidence suggests that this imaging device is effective for capturing eye floaters?

Research shows that eye floaters, technically known as symptomatic vitreous opacities (SVO), can significantly affect vision and overall quality of life. Studies have found that these floaters can blur images and make it difficult to distinguish different shades of gray. In this trial, participants will have their eyes imaged using a new device, SVO-ID, designed to capture detailed pictures of these floaters. While the device's ability to treat floaters remains unknown, the researchers aim to build a large collection of images. This could enhance understanding and management of floaters in the future. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing eye floaters or vitreous opacities. Specific eligibility criteria are not provided, but typically participants would need to have the condition being studied and meet certain health requirements.

Inclusion Criteria

My eyes are clear enough for a detailed internal examination.

I experience noticeable floaters in my vision.

Exclusion Criteria

I have severe cataracts.

I have cloudiness in my eye's lens, cornea, or vitreous.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants will have their eyes imaged with the SVO-ID device to capture images of their floaters

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

6-8 months

What Are the Treatments Tested in This Trial?

Interventions

• SVO-ID

Trial Overview

The study involves using a new ophthalmic imaging device called SVO-ID to take pictures of eye floaters in patients. The aim is to create an image database that can help understand these conditions better.

How Is the Trial Designed?

Group I: Imaging using the SVO-ID Experimental Treatment 1 Intervention

Patients will have their eyes imaged with the SVO-ID as part of a study visit.

Who Is Running the Clinical Trial?

PulseMedica

Lead Sponsor

Trials

3

Recruited

340+

Published Research Related to This Trial

Dynamic widefield scanning laser ophthalmoscopy (SLO) was rated significantly higher by patients for accurately representing their visual perception of floaters compared to B-scan ultrasonography, with median scores of 9 and 5 respectively, based on a study of 21 patients.

SLO imaging revealed complex three-dimensional structures and movements of vitreous abnormalities, suggesting that floaters are manifestations of intricate degenerative changes in the vitreous rather than simple entities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

THE WAY PATIENTS SEE FLOATERS: Widefield Dynamic Scanning Laser Ophthalmoscopy Imaging of Vitreous Abnormalities. Ngo, WK., Keshet, Y., Salcedo-Ledesma, A., et al.[2023]

Laser vitreolysis, a treatment for symptomatic vitreous floaters using an Nd:YAG laser, is becoming more common, but there is insufficient data on its long-term safety and effectiveness.

The authors recommend that laser vitreolysis should not be routinely performed until more studies confirm its safety and efficacy, and it receives FDA approval based on comprehensive trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser vitreolysis for symptomatic floaters is not yet ready for widespread adoption. Su, D., Shah, CP., Hsu, J.[2021]

Floaters, or symptomatic vitreous opacities, can significantly impair vision-related quality of life for some patients, despite being a common condition associated with aging.

Recent evidence suggests that small-gauge vitrectomy is a safe and effective treatment option for floaters, although patients should be aware of the psychological factors influencing their decision to pursue surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitrectomy for primary symptomatic vitreous opacities: an evidence-based review. Ivanova, T., Jalil, A., Antoniou, Y., et al.[2022]

Patients with symptomatic vitreous floaters (SVF) showed a higher prevalence of depressive symptoms compared to healthy controls, with 53.6% of SVF patients classified as depressed before surgery.

Vitrectomy surgery significantly improved depressive symptoms in SVF patients, as evidenced by a reduction in CES-D scores from 18.3 to 11.9 and a decrease in the proportion of patients in a depressive state from 53.6% to 18.5% one week after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pars plana vitrectomy relieves the depression in patients with symptomatic vitreous floaters. Wu, RH., Jiang, JH., Gu, YF., et al.[2020]

In a study of 196 patients experiencing their first vitreous floaters, 62.2% showed peripapillary vitreous opacity, and 94.3% of those with available data had acute symptomatic posterior vitreous detachment (PVD), indicating a strong association between floaters and PVD.

Patients with floaters were found to be more myopic and had lower intraocular pressure compared to symptom-free eyes, suggesting that these factors may be linked to the development of floaters and PVD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute symptomatic vitreous floaters assessed with ultra-wide field scanning laser ophthalmoscopy and spectral domain optical coherence tomography. Son, G., Sohn, J., Kong, M.[2021]

A new surgical method called vitreous opacity vitrectomy (VOV) was developed specifically for safely removing extensive symptomatic vitreous opacities (SVO) in patients with degenerative vitreous syndrome (DVS), showing promising results in a study of 100 operations with no significant complications reported during a year of follow-up.

The VOV procedure not only restored clear vision for all patients but also aimed to minimize the risk of retinal detachment by ensuring careful vitreous removal and thorough examination of the peripheral retina, thus maintaining a favorable risk/benefit ratio for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitreous Opacity Vitrectomy (VOV): Safest Possible Removal of "Floaters". Morris, RE.[2022]

The introduction of the VFO and SK VFO Test provides a new standardized method for assessing symptoms of vitreous floaters and opacities, which could lead to more personalized treatment options for patients.

In a study involving eight eyes that underwent limited vitrectomy, 87.5% showed significant improvement in visual function, indicating that this new assessment method effectively identifies and evaluates the impact of vitreous conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Terminology and Methodology for the Assessment of the Vitreous, Its Floaters and Opacities, and Their Effect on Vision: Standardized and Kinetic Anatomical and Functional Testing of Vitreous Floaters and Opacities (SK VFO Test). Stanga, PE., Valentin Bravo, FJ., Reinstein, UI., et al.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06204848

Imaging of Vitreous Opacities in a Canadian Population

The goal of this clinical trial is to capture imaging data of eye floaters ... Clear ocular media, to allow a clear view of the vitreous for the SVO-ID.

2.

retinatoday.com

retinatoday.com/articles/2021-nov-dec-supplement4/survey-findings-on-vitreous-opacities-and-expert-panel-recommendations-on-the-referral-and-management-of-symptomatic-vitreous-opacity-cases

Survey Findings on Vitreous Opacities and Expert Panel ...

VO symptoms are minimal in most patients; however, symptomatic vitreous opacities (SVO) can cause significant impairment in vision-related quality of life (QoL) ...

3.

trialx.com

trialx.com/clinical-trials/listings/288794/imaging-of-vitreous-opacities-in-human-eyes/

Imaging of Vitreous Opacities in Human Eyes

This study aims to obtain imaging data of VOs in the population to build an imaging database of VOs to learn more about them. Eligibility.

4.

withpower.com

withpower.com/trial/phase-eye-diseases-1-2024-7d21d

Imaging for Vitreous Floaters · Info for Participants

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.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6810832/

Real-World Assessment of Vitreous Structure and Visual ...

Vitreous echodensity (QUS) was 43% greater (p<0.001) and contrast sensitivity function (CSF) was 118% worse (p<0.001) in eyes with vitreous floaters, probably ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12360991/

The impact of vitreous floaters on quality of life - PubMed Central

Vitreous floaters result in specific quality-of-life issues that have not been adequately measured with previous patient-reported outcome ...