Skip to main content
OpenTrials
Recruiting

NCT Number: 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) 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Posterior Vitreous Detachment Eye Diseases Myopic Vitreopathy VISION DEGRADING MYODESOPSIA Vitreous Detachment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VMR Institute for Vitreous Macula Retina

Huntington Beach, California, 92647, United States

Location status: Recruiting

Location contact

Dr. Jerry Sebag, MD, FACS, FRCOphth, FARVO

CONTACT

[email protected]

714-901-7777

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Nd:YAG laser treatment(s) for Vision Degrading Myodesopsia (clinically significant vitreous floaters) in eyes with vitreous opacities due to myopic vitreopathy and posterior vitreous detachment (PVD).

Primary outcomes

  1. Measures of vitreous structure by quantitative ultrasonography

    Time frame: baseline, 3 months, 6 months, 12 months

Secondary outcomes

  1. Measures of visual function using contrast sensitivity

    Time frame: baseline, 3 months, 6 months, 12 months

  2. Evaluation of quality of life using Visual Function Questionnaire (VFQ-25)

    Time frame: baseline, 3 months, 6 months, 12 months

    Individual scores (NEI VFQ 25 score) are recoded and transformed on a scale from 0 to 100, where 100 represents the best possible performance and 0 represents the worst

  3. Evaluation of quality of life using Vitreous Floater Functional Questionnaire (VFFQ)

    Time frame: baseline, 3 months, 6 months, 12 months

    Individual scores (VFFQ score) are recoded and transformed on a scale from 0 to 100, where 100 represents the best possible performance and 0 represents the worst

  4. Evaluation of Visual Acuity (ETDRS LogMAR)

    Time frame: baseline, 3 months, 6 months, 12 months

  5. Evaluation of Near Visual Acuity

    Time frame: baseline, 3 months, 6 months, 12 months

  6. Evaluation of retinal electrical activity changes in response to light stimuli (Photopic Negative Response amplitude) using Electroretinography (ERG)

    Time frame: baseline, 3 months, 6 months, 12 months

  7. Visual evaluation of retinal structure changes in sagittal mode using optical coherence tomography (OCT) centered on the fovea

    Time frame: baseline, 3 months, 6 months, 12 months

  8. Evaluation of central visual field changes (median light sensitivity) using microperimetry

    Time frame: baseline, 3 months, 6 months, 12 months

    Scale 0-36dB (0 worst condition; 36dB the best condition)

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Jerry Sebag, MD, FACS, FRCOphth, FARVO

CONTACT

[email protected]

714-901-7777

Sponsors and collaborators

Lead sponsor

VMR Consulting, Inc.

Other

Collaborators

  • The Retina Clinic - London Ophthalmic Institute

Registry information

Official study title

Therapeutic Neodymium-doped Yttrium-Aluminum-Garnet (Nd:YAG) Laser Vitreolysis for Vitreous Floaters - A Study to Quantify Visual Quality of Life, Vitreous Structure, and Vision Before and After Nd:YAG Laser Vitreolysis in Patients With Vision Degrading Myodesopsia

Acronym: YLV Protocol

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.