Posterior Vitreous DetachmentYLV ProtocolNCT06915922
YAG Laser Vitreolysis for Vitreous Floaters
A study testing Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser therapy in people with Posterior Vitreous Detachment and Myopic Vitreopathy, run by VMR Consulting, Inc. at 1 site in United States.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posterior Vitreous Detachment, Myopic Vitreopathy, VISION DEGRADING MYODESOPSIA
- What is being tested?
- Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2023to 13 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VMR Institute for Vitreous Macula Retina
Huntington Beach, California, 92647
About this study
Official 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
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.
- Being tested
- Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser therapy
- Medical subject headings
- Vitreous Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser therapyDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Neodymium-doped Yttrium-Aluminum-Garnet (Nd:YAG) Laser Vitreolysis | Other | Not described Receives: Device: Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of vitreous structure by quantitative ultrasonography
Measured: baseline, 3 months, 6 months, 12 months
Secondary outcomes (8)
Measures of visual function using contrast sensitivity
Measured: baseline, 3 months, 6 months, 12 months
Evaluation of quality of life using Visual Function Questionnaire (VFQ-25)
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
Measured: baseline, 3 months, 6 months, 12 months
Evaluation of quality of life using Vitreous Floater Functional Questionnaire (VFFQ)
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
Measured: baseline, 3 months, 6 months, 12 months
Evaluation of Visual Acuity (ETDRS LogMAR)
Measured: baseline, 3 months, 6 months, 12 months
Evaluation of Near Visual Acuity
Measured: baseline, 3 months, 6 months, 12 months
Evaluation of retinal electrical activity changes in response to light stimuli (Photopic Negative Response amplitude) using Electroretinography (ERG)
Measured: baseline, 3 months, 6 months, 12 months
Visual evaluation of retinal structure changes in sagittal mode using optical coherence tomography (OCT) centered on the fovea
Measured: baseline, 3 months, 6 months, 12 months
Evaluation of central visual field changes (median light sensitivity) using microperimetry
Scale 0-36dB (0 worst condition; 36dB the best condition)
Measured: baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start17 Oct 2023
- Primary completion13 Aug 2026
- Study completion13 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Vitreous DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- VMR Consulting, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- The Retina Clinic - London Ophthalmic Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915922
- Sponsor's protocol ID
- 2023000367
- Acronym
- YLV Protocol
- Status last verified
- Sep 2026
- First submitted
- 26 Mar 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06915922
- Acronym / sponsor ID
- YLV Protocol / 2023000367
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- VMR Consulting, Inc.University, hospital or other
- Collaborators
- The Retina Clinic - London Ophthalmic Institute
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 13 Aug 2026 (actual)
- Study completion
- 13 Aug 2026 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neodymium-doped Yttrium-Aluminum-Garnet (Nd:YAG) Laser Vitreolysis | Other | Device: Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser therapyNd: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). | Device | Neodymium-doped Yttrium-Aluminum-Garnet (Nd:YAG) Laser Vitreolysis |
Primary outcome
Measures of vitreous structure by quantitative ultrasonography
Time frame: baseline, 3 months, 6 months, 12 months
8 secondary outcomes
Measures of visual function using contrast sensitivity
Time frame: baseline, 3 months, 6 months, 12 months
Evaluation of quality of life using Visual Function Questionnaire (VFQ-25)
Time frame: baseline, 3 months, 6 months, 12 months
Evaluation of quality of life using Vitreous Floater Functional Questionnaire (VFFQ)
Time frame: baseline, 3 months, 6 months, 12 months
Evaluation of Visual Acuity (ETDRS LogMAR)
Time frame: baseline, 3 months, 6 months, 12 months
Evaluation of Near Visual Acuity
Time frame: baseline, 3 months, 6 months, 12 months
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
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
Evaluation of central visual field changes (median light sensitivity) using microperimetry
Time frame: baseline, 3 months, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser therapy in people with Posterior Vitreous Detachment and Myopic Vitreopathy, run by VMR Consulting, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures of vitreous structure by quantitative ultrasonography (time frame: baseline, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.