Status:
RECRUITING
YAG Laser Vitreolysis for Vitreous Floaters
Lead Sponsor:
VMR Consulting, Inc.
Collaborating Sponsors:
Quantel Medical
Conditions:
Posterior Vitreous Detachment
Myopic Vitreopathy
Eligibility:
All Genders
18+ years
Phase:
NA
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 caus...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06915922
Start Date
October 17 2023
End Date
May 1 2026
Last Update
April 8 2025
Active Locations (1)
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1
VMR Institute for Vitreous Macula Retina
Huntington Beach, California, United States, 92647