YAG Laser for Eye Floaters

(YLV Protocol Trial)

Overseen By Dr Jerry Sebag, MD, FACS, FRCOphth, FARVO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VMR Consulting, Inc.

Disqualifiers: Cataract, Retinal tears, Vitreous hemorrhage, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser therapy can improve vision and quality of life for individuals with eye floaters. Eye floaters, small spots or shapes drifting in vision, often result from changes in the eye's gel. The treatment employs a special laser, already approved by the FDA, to reduce these floaters. Individuals with noticeable floaters for over three months who experience vision problems may be suitable candidates. As an unphased trial, this study provides an opportunity to explore a treatment that could enhance daily life by reducing vision disturbances.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this Nd:YAG laser therapy is safe for treating eye floaters?

Research has shown that Nd:YAG laser treatment is generally well-tolerated for treating eye floaters. The FDA has approved this laser for other eye conditions, suggesting it is likely safe.

Studies indicate that serious risks are rare but can include increased eye pressure, glaucoma (which can harm the optic nerve), and cataracts (clouding of the eye's lens). These occur in about 1 out of every 100 patients. To minimize the risk of eye damage, the laser targets only floaters that are safely away from the retina, which detects light and sends images to the brain.

Overall, Nd:YAG laser therapy appears to be a safe option for treating floaters, with many patients experiencing good results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for eye floaters, which often include watchful waiting or invasive surgery, the Nd:YAG laser therapy offers a non-invasive approach. This laser treatment targets the floaters directly, vaporizing them into smaller, less noticeable pieces. Researchers are excited because this method could provide quicker relief without the risks associated with surgery and could be a game-changer for those struggling with the visual disturbances caused by floaters.

What evidence suggests that the Nd:YAG laser is effective for treating eye floaters?

Research has shown that using the Nd:YAG laser to treat eye floaters can improve vision. In this trial, participants will receive Nd:YAG laser vitreolysis. Studies have found that after this laser treatment, many patients experienced clearer vision and less cloudiness from floaters. Specifically, one study found that 43 out of 51 eyes showed improvement after treatment. Additionally, the procedure did not significantly change eye pressure or overall vision sharpness, indicating it is a safe option for many people. Overall, the Nd:YAG laser effectively reduces the bothersome effects of eye floaters. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing 'floaters' in their vision, often due to vitreous opacities. Participants should have symptoms that affect their quality of life or vision and may include those with posterior vitreous detachment or myopia.

Inclusion Criteria

Floaters meeting the following characteristics: Present for ≥3 months, One single or more dense and well-defined vitreous opacities, A Weiss Ring or opacities which are within the safety area, at least 3mm away from the retina and 6mm away from the lens, Visible on contact lens biomicroscopy

Only one eye per patient will be included in this study

Able and willing to give informed consent

Exclusion Criteria

I have cloudy vision from old blood in my eye.

I see flashing lights that aren't there.

I have not had retinal laser surgery in the last 2 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Nd:YAG laser treatment for vitreous floaters

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in quality of life and vision after treatment

12 months

Multiple visits at baseline, 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser therapy

Trial Overview The study tests the effectiveness of Nd:YAG laser therapy on improving the quality of life and vision for people with eye floaters. It aims to see how this FDA-approved treatment changes the structure of the eye's gel (vitreous) after use.

How Is the Trial Designed?

Group I: Neodymium-doped Yttrium-Aluminum-Garnet (Nd:YAG) Laser Vitreolysis Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

VMR Consulting, Inc.

Lead Sponsor

Quantel Medical

Industry Sponsor

Trials

4

Recruited

290+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06915922

NCT06915922 | YAG Laser Vitreolysis for Vitreous Floaters The purpose of this study is to measure how the quality of life, the structure of eye, and vision change after treatment for the opacities in the gel (vitreous) ...

2. journals.lww.com journals.lww.com/ijo/fulltext/2022/08000/the_effectiveness_of_laser_vitreolysis_for.53.aspx

The effectiveness of laser vitreolysis for vitreous floaters Twelve patients had both eyes lasered and 33 patients had one eye lasered. The mean CSF improved from 3.20 ± 0.85%W to 2.64 ± 0.63%W 1 month after vitreolysis.

3. isrctn.com isrctn.com/ISRCTN12191616

Study evaluating the safety and efficacy of YAG laser for ... The objective of this study was to evaluate the efficacy and safety of YAG laser vitreolysis in the treatment of vitreous floaters. Who can participate?

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7140748/

Safety and Efficacy of YAG Laser Vitreolysis for the Treatment ... To minimize the chances of ocular damage, YAG laser treatment was only performed for floaters having a distance longer that 2 mm from the retina ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2019/8956952

Nd:YAG Laser Vitreolysis for Symptomatic Vitreous ... There were no significant changes in intraocular pressure and visual acuity after the laser treatment. 43 eyes had improved symptoms; in 8, ...

6. karger.com karger.com/cop/article/13/2/511/822597/Visually-Disturbing-Vitreous-Floaters-following

Visually Disturbing Vitreous Floaters following Neodymium ... This study aimed to report the risk factors and treatment outcomes of visually disturbing vitreous opacities after neodymium-doped yttrium aluminum garnet (Nd: ...

7. journals.lww.com journals.lww.com/ejrj/fulltext/2019/06010/one_year_follow_up_of_patients_after_yttrium.1.aspx

One-year Follow-up of Patients after Yttrium Aluminum... Conclusions: Laser vitreolysis is a safe, effective method for the treatment of symptomatic visually disturbing floaters. INTRODUCTION. In ...