Weiss RingVVFNCT05800353
Nd:YAG Laser Vitreolysis for Symptomatic Vitreous Floaters
A study testing YAG vitreolysis in people with Weiss Ring, run by Dongyang People's Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to compare in the efficacy and safety of Nd:YAG laser vitreolysis for symptomatic vitreous floaters. The main question it aims to answer are: examine the efficacy and safety in treating early onset of vitreous floaters （Weiss ring） using Nd:YAG laser vitreolysis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Weiss Ring
- What is being tested?
- YAG vitreolysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2022to 31 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Self-rating of visual disturbance by the floaters must be at least 4 on a 0-10 scale, with 0 being no symptoms to 10 being debilitating symptoms.
- Symptomatic Weiss ring (PVD) must be at least 2mm away from the retina and 5 mm from the posterior lens capsule of the crystalline lens, as measured on B-scan. For pseudophakic patients, there is no minimum required distance from the intraocular lens.
- Able to position for the YAG laser procedure.
- Accept the risks of YAG laser including but not limited to retinal detachment, intraocular hemorrhage, retinal damage, cataract formation, optic nerve damage, inflammation, and irreversible loss of vision.
- Willing and able to comply with clinic visits and study-related procedures
- If the patient has two symptomatic eyes, only one eye can be randomized and included in the study.
- Provide signed informed consent
Who cannot join
- History of retinal tear, retinal detachment, or uveitis in the study eye
- History of diabetic retinopathy, macular edema, retinal vein occlusion, or aphakia in the study eye
- History of glaucoma or high intraocular pressure defined as having a history of glaucoma surgery or currently taking two or more topical glaucoma medications in the study eye
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to compare in the efficacy and safety of Nd:YAG laser vitreolysis for symptomatic vitreous floaters. The main question it aims to answer are:
- examine the efficacy and safety in treating early onset of vitreous floaters （Weiss ring） using Nd:YAG laser vitreolysis.
Read more
Participants with symptomatic floaters for one month will be randomly divided into two groups：early treatment group and delayed treatment group. Participants in the early treatment group will receive a YAG laser vitreolysis immediately and a sham laser treatment three months later, while participants in the delayed treatment group will receive a sham laser treatment immediately and a YAG laser vitreolysis three months late.
Researchers will compare the two groups to see the efficacy and safety of early YAG laser vitreolysis for symptomatic vitreous floaters.
- Conditions
- Weiss Ring
- Being tested
- YAG vitreolysis
- Keywords
- Vitreous floaters, vitreolysis, Nd:YAG laser
- Medical subject headings
- vitreous floaters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YAG vitreolysisProcedure or surgery
Also called Sham YAG vitreolysis
A Karickoff lens with goniosol will be used to perform the YAG vitreolysis. The number of shots will be determined at the discretion of the treating physician. A focus offset may be used at investigator discretion. Single shot mode will be used. The maximum energy per pulse will be 7 mJ. The endpoint of treatment is the vaporization of the Weiss ring into gas, as well as the disruption of it into smaller fragments as well as any other vitreous opacities deemed visually significant by the treating physician.
Sham laser treatment will be applied under the same procedure used for laser treatment but by turning the laser power down to 0.3 mJ and using a separate lens covered by a filter that absorbs the power, so no laser enters the eye.
| Study group | Role | What they receive |
|---|---|---|
| early treatment group | Experimental | Participants in the early treatment group will receive a YAG laser vitreolysis immediately and a sham laser treatment three months later. Receives: Procedure: YAG vitreolysis |
| delayed treatment group | Experimental | Participants in the delayed treatment group will receive a sham laser treatment immediately and a YAG laser vitreolysis three months late. Receives: Procedure: YAG vitreolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective improvement in floater symptoms
Doctor/Surveyor: Hi there, have you experienced any visual disturbances such as floaters? On a scale of 0 to 10, with 0 meaning no symptoms and 10 meaning symptoms that significantly impact your daily life, how would you rate the severity of your visual disturbance caused by the floaters?
Measured: 3 Months
Visual Functioning Questionnaire-25
Mean change in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25). The Visual Functioning Questionnaire-25 (VFQ-25) is a self-reported questionnaire designed to measure a patient's visual function and its impact on their quality of life. The VFQ-25 consists of 25 items, which assess various domains of vision-related quality of life, such as general vision, near and distance activities, driving, social functioning, and mental health. The minimum value for the VFQ-25 is 0, which represents the worst possible visual function and quality of life, while the maximum value is 100, indicating the best possible visual function and quality of life. Higher scores on the VFQ-25 indicate a better outcome, indicating that the patient has better visual function and quality of life.
Measured: 3 Months
Secondary outcomes (2)
Qualitative changes through OCT and fundus photography
The objective evaluation of the improvement of vitreous floaters through OCT and fundus photography can be divided into five levels: worse, no change, mild improvement, significant improvement, and complete improvement.
Measured: 3 Months
Incidence and severity of ocular and systemic adverse events
Incidence rates of retinal tears, retinal hemorrhage, retinal detachment, lens damage, and other related adverse events.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start22 Nov 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weiss RingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongyang People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Hangshuai, Dongyang People's Hospital
- Investigators
- Guangjin Zhao, Study chair, Dongyang People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800353
- Sponsor's protocol ID
- DongyangPH
- Acronym
- VVF
- Status last verified
- Oct 2025
- First submitted
- 10 Mar 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hangshuai Z, Yanhua J, Yao Z, Guangjin Z, Hongyan W, Fanlian C. Efficacy and safety of early YAG laser vitreolysis for symptomatic vitreous floaters: the study protocol for a randomized clinical trial. Trials. 2024 Jan 13;25(1):48. doi: 10.1186/s13063-024-07924-1.
PubMed 38218919
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nd:YAG Laser Vitreolysis for Symptomatic Vitreous Floaters
- ClinicalTrials.gov ID
- NCT05800353
- Acronym / sponsor ID
- VVF / DongyangPH
- Conditions
- Weiss Ring
- Keywords
- Vitreous floaters, vitreolysis, Nd:YAG laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dongyang People's HospitalUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Apr 2023 (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 goal of this clinical trial is to compare in the efficacy and safety of Nd:YAG laser vitreolysis for symptomatic vitreous floaters. The main question it aims to answer are:
- examine the efficacy and safety in treating early onset of vitreous floaters （Weiss ring） using Nd:YAG laser vitreolysis.
Participants with symptomatic floaters for one month will be randomly divided into two groups：early treatment group and delayed treatment group. Participants in the early treatment group will receive a YAG laser vitreolysis immediately and a sham laser treatment three months later, while participants in the delayed treatment group will receive a sham laser treatment immediately and a YAG laser vitreolysis three months late.
Researchers will compare the two groups to see the efficacy and safety of early YAG laser vitreolysis for symptomatic vitreous floaters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early treatment group | Experimental | Procedure: YAG vitreolysisParticipants in the early treatment group will receive a YAG laser vitreolysis immediately and a sham laser treatment three months later. |
| delayed treatment group | Experimental | Procedure: YAG vitreolysisParticipants in the delayed treatment group will receive a sham laser treatment immediately and a YAG laser vitreolysis three months late. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Self-rating of visual disturbance by the floaters must be at least 4 on a 0-10 scale, with 0 being no symptoms to 10 being debilitating symptoms.
- Symptomatic Weiss ring (PVD) must be at least 2mm away from the retina and 5 mm from the posterior lens capsule of the crystalline lens, as measured on B-scan. For pseudophakic patients, there is no minimum required distance from the intraocular lens.
- Able to position for the YAG laser procedure.
- Accept the risks of YAG laser including but not limited to retinal detachment, intraocular hemorrhage, retinal damage, cataract formation, optic nerve damage, inflammation, and irreversible loss of vision.
- Willing and able to comply with clinic visits and study-related procedures
Key exclusion criteria (3 listed)
- History of retinal tear, retinal detachment, or uveitis in the study eye
- History of diabetic retinopathy, macular edema, retinal vein occlusion, or aphakia in the study eye
- History of glaucoma or high intraocular pressure defined as having a history of glaucoma surgery or currently taking two or more topical glaucoma medications in the study eye
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 |
|---|---|---|
| YAG vitreolysisAlso: Sham YAG vitreolysisA Karickoff lens with goniosol will be used to perform the YAG vitreolysis. The number of shots will be determined at the discretion of the treating physician. A focus offset may be used at investigator discretion. Single shot mode will be used. The maximum energy per pulse will be 7 mJ. The endpoint of treatment is the vaporization of the Weiss ring into gas, as well as the disruption of it into smaller fragments as well as any other vitreous opacities deemed visually significant by the treating physician. Sham laser treatment will be applied under the same procedure used for laser treatment but by turning the laser power down to 0.3 mJ and using a separate lens covered by a filter that absorbs the power, so no laser enters the eye. | Procedure or surgery | delayed treatment group, early treatment group |
Primary outcome
Subjective improvement in floater symptoms
Time frame: 3 Months
Doctor/Surveyor: Hi there, have you experienced any visual disturbances such as floaters? On a scale of 0 to 10, with 0 meaning no symptoms and 10 meaning symptoms that significantly impact your daily life, how would you rate the severity of your visual disturbance caused by the floaters?
Visual Functioning Questionnaire-25
Time frame: 3 Months
Mean change in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25). The Visual Functioning Questionnaire-25 (VFQ-25) is a self-reported questionnaire designed to measure a patient's visual function and its impact on their quality of life. The VFQ-25 consists of 25 items, which assess various domains of vision-related quality of life, such as general vision, near and distance activities, driving, social functioning, and mental health. The minimum value for the VFQ-25 is 0, which represents the worst possible visual function and quality of life, while the maximum value is 100, indicating the best possible visual function and quality of life. Higher scores on the VFQ-25 indicate a better outcome, indicating that the patient has better visual function and quality of life.
2 secondary outcomes
Qualitative changes through OCT and fundus photography
Time frame: 3 Months
Incidence and severity of ocular and systemic adverse events
Time frame: 3 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 2 Oct 2025.
- Derived from this study: PubMed 38218919Hangshuai Z, Yanhua J, Yao Z, Guangjin Z, Hongyan W, Fanlian C. Efficacy and safety of early YAG laser vitreolysis for symptomatic vitreous floaters: the study protocol for a randomized clinical trial. Trials. 2024 Jan 13;25(1):48. doi: 10.1186/s13063-024-07924-1.
- Individual participant dataSharing planned: No
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.
Guangjin Zhao study chair
Dongyang People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YAG vitreolysis in people with Weiss Ring, run by Dongyang People's Hospital at 1 site in China.
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 7 inclusion and 3 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 2 Oct 2025. 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 China. 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?
Subjective improvement in floater symptoms (time frame: 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05800353, which also lists 1 linked publication.
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 2 Oct 2025.