YAG Laser Vitreolysis for Vitreous Floaters

NCT06915922 | Recruiting FDA Device

• 1 other identifier: 2023000367
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopic Vitreopathy; VISION DEGRADING MYODESOPSIA; Posterior Vitreous Detachment

Outcome Measures

Primary Outcomes (1)

• Measures of vitreous structure by quantitative ultrasonography

  baseline, 3 months, 6 months, 12 months

Secondary Outcomes (8)

• Measures of visual function using contrast sensitivity

  baseline, 3 months, 6 months, 12 months

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

  baseline, 3 months, 6 months, 12 months

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

  baseline, 3 months, 6 months, 12 months

• Evaluation of Visual Acuity (ETDRS LogMAR)

  baseline, 3 months, 6 months, 12 months

• Evaluation of Near Visual Acuity

  baseline, 3 months, 6 months, 12 months

Study Arms (1)

Neodymium-doped Yttrium-Aluminum-Garnet (Nd:YAG) Laser Vitreolysis

OTHER

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

Interventions

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).

Neodymium-doped Yttrium-Aluminum-Garnet (Nd:YAG) Laser Vitreolysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VMR Consulting, Inc.: lead
• The Retina Clinic - London Ophthalmic Institute: collaborator

Study Sites (1)

VMR Institute for Vitreous Macula Retina

Huntington Beach, California, 92647, United States

RECRUITING

MeSH Terms

Conditions

Vitreous Detachment

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Dr Jerry Sebag, MD, FACS, FRCOphth, FARVO

CONTACT

714-901-7777; JSebag@vmrinstitute.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 8, 2025
• Study Start: October 17, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)