YAG Laser Vitreolysis for Vitreous Floaters (YLV Protocol)

VMR Consulting, Inc.

Status

Enrolling

Conditions

VISION DEGRADING MYODESOPSIA

Myopic Vitreopathy

Posterior Vitreous Detachment

Treatments

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06915922

2023000367

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Only one eye per patient will be included in this study
Able and willing to give informed consent
Age ≥18 years
Suffering from symptomatic vitreous floaters
Floaters arising from either/both:
- myopic vitreopathy
- posterior vitreous detachment
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

Exclusion criteria

Patient presenting with vitreous opacities outside of the described safety area (within 3mm of the retina or 6mm from the lens)
Have clinically significant cataract (lens opacification) in one or both eyes which are in the opinion of the examining doctor more significant in impacting vision as compared to that caused by vitreous opacities; or cataract expected to need cataract surgery during the duration of the study
Present with untreated retinal tears or retinal holes requiring treatment at the discretion of the study investigator
Have high risk of peripheral lesions requiring treatment at the discretion of the study investigator
Have synchysis scintillans (unusual vitreous opacities from old blood)
Have asteroid hyalosis (unusual vitreous opacities from cholesterol)
Have vitreous hemorrhage (fresh blood in the center of the eye)
Have active photopsia (flashing lights)
History of previous YAG laser vitreolysis treatments, or vitrectomy for any condition (retinal detachment, proliferative diabetic retinopathy, etc.)
Have Posterior Vitreous Detachment (separation of vitreous away from the retina lining the inside of the back of the eye) within the past 3 months
Are unable to attend study appointments
Have any other significant ocular or non-ocular condition that, at the discretion of the study investigator, puts the subject at risk or influences the results of the study
History of intraocular surgery within 6 months from study entry
History of retinal laser within 2 months from study entry