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

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. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser therapy for eye floaters?

Research on Nd:YAG laser therapy for eye floaters shows mixed results. Some studies suggest it can improve vision by reducing floaters, but there are concerns about potential side effects like cataracts and glaucoma. ^{1 2 3 4 5}

Is Nd:YAG laser treatment for eye floaters safe?

Nd:YAG laser treatment for eye floaters is generally considered safe, but there are some risks. While many studies report no complications, there have been rare cases of retinal damage, which can lead to vision problems. ^{1 4 5 6 7}

How does Nd:YAG laser treatment for eye floaters differ from other treatments?

The Nd:YAG laser treatment for eye floaters is unique because it uses laser energy to break up the floaters in the eye, providing immediate symptom relief without the need for surgery. Unlike other treatments, it is non-invasive and has been shown to be simple, safe, and effective, although long-term safety and efficacy are still under evaluation. ^{1 2 3 4 7}

What is the purpose of this trial?

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) that fills the center of eye which cause vision disturbances commonly called "floaters". In this study the vitreous floaters are treated using a Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser. The FDA has approved the use of this laser to treat membranes in the eye.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Assessment of Vitreous Structure and Visual Function after Neodymium:Yttrium-Aluminum-Garnet Laser Vitreolysis. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Cataracts induced by neodymium-yttrium-aluminium-garnet laser lysis of vitreous floaters. [2022]

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

Refractory open-angle glaucoma after neodymium-yttrium-aluminum-garnet laser lysis of vitreous floaters. [2022]

4. Brazil pubmed.ncbi.nlm.nih.gov

Long-term evaluation of the efficacy and safety of Nd:YAG laser vitreolysis for symptomatic vitreous foaters. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of yttrium-aluminium garnet (YAG) laser vitreolysis for vitreous floaters. [2019]

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

Retinal Complications after Yttrium-Aluminum-Garnet Laser Vitreolysis for Vitreous Floaters. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Treatment of vitreous floaters with neodymium YAG laser. [2022]