Back to resultsNd:YAG Laser Vitreolysis for Symptomatic Vitreous Floaters (VVF)
Primary Purpose
Weiss Ring
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
YAG vitreolysis
Sponsored by
About this trial
This is an interventional treatment trial for Weiss Ring focused on measuring Vitreous floaters, vitreolysis, Nd:YAG laser
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Dongyang People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
early treatment group
delayed treatment group
Arm Description
Participants in the early treatment group will receive a YAG laser vitreolysis immediately and a sham laser treatment three months later.
Participants in the delayed treatment group will receive a sham laser treatment immediately and a YAG laser vitreolysis three months late.
Outcomes
Primary Outcome Measures
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?
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05800353
First Posted
March 10, 2023
Last Updated
April 4, 2023
Sponsor
Dongyang People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05800353
Brief Title
Nd:YAG Laser Vitreolysis for Symptomatic Vitreous Floaters
Acronym
VVF
Official Title
Nd:YAG Laser Vitreolysis for Symptomatic Vitreous Floaters
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongyang People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weiss Ring
Keywords
Vitreous floaters, vitreolysis, Nd:YAG laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
early treatment group
Arm Type
Experimental
Arm Description
Participants in the early treatment group will receive a YAG laser vitreolysis immediately and a sham laser treatment three months later.
Arm Title
delayed treatment group
Arm Type
Experimental
Arm Description
Participants in the delayed treatment group will receive a sham laser treatment immediately and a YAG laser vitreolysis three months late.
Intervention Type
Procedure
Intervention Name(s)
YAG vitreolysis
Other Intervention Name(s)
Sham YAG vitreolysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjective improvement in floater symptoms
Description
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?
Time Frame
3 Months
Title
Visual Functioning Questionnaire-25
Description
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.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Qualitative changes through OCT and fundus photography
Description
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.
Time Frame
3 Months
Title
Incidence and severity of ocular and systemic adverse events
Description
Incidence rates of retinal tears, retinal hemorrhage, retinal detachment, lens damage, and other related adverse events.
Time Frame
3 Months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hangshuai Zhou
Phone
+8618867940019
Email
350589935@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guangjin Zhao
Organizational Affiliation
Dongyang People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Dongyang People's Hospital
City
Dongyang
State/Province
Zhejiang
ZIP/Postal Code
322100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hangshuai Zhou
Phone
+8618867940019
Email
350589935@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nd:YAG Laser Vitreolysis for Symptomatic Vitreous Floaters
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