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

125 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

Is the treatment for vitreous floaters safe?

Vitrectomy, a surgical treatment for vitreous floaters, has been studied for its safety and is considered to have minimal risk when performed by specialists. However, laser vitreolysis, another treatment option, lacks sufficient long-term safety data and is not recommended for widespread use until more studies are conducted. ^{1 2 3 4 5}

How does the imaging treatment for vitreous floaters differ from other treatments?

The imaging treatment for vitreous floaters is unique because it uses advanced imaging techniques like widefield dynamic scanning laser ophthalmoscopy to better visualize and assess the floaters, which can help in planning more precise interventions. This approach is different from traditional treatments like vitrectomy, which involves surgically removing the vitreous gel to eliminate floaters. ^{1 2 5 6 7}

What is the purpose of this trial?

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. Participants will imaged with an investigational ophthalmic imaging device to capture images of their floaters.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Vitrectomy for primary symptomatic vitreous opacities: an evidence-based review. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Laser vitreolysis for symptomatic floaters is not yet ready for widespread adoption. [2021]

4. China pubmed.ncbi.nlm.nih.gov

Pars plana vitrectomy relieves the depression in patients with symptomatic vitreous floaters. [2020]

5. United States 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). [2023]

6. England pubmed.ncbi.nlm.nih.gov

Acute symptomatic vitreous floaters assessed with ultra-wide field scanning laser ophthalmoscopy and spectral domain optical coherence tomography. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

THE WAY PATIENTS SEE FLOATERS: Widefield Dynamic Scanning Laser Ophthalmoscopy Imaging of Vitreous Abnormalities. [2023]