Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-10-17
2026-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Neodymium-doped Yttrium-Aluminum-Garnet (Nd:YAG) Laser Vitreolysis
Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser therapy
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).
Interventions
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Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser therapy
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Quantel Medical
INDUSTRY
VMR Consulting, Inc.
OTHER
Responsible Party
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Locations
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VMR Institute for Vitreous Macula Retina
Huntington Beach, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023000367
Identifier Type: -
Identifier Source: org_study_id
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