Nd:YAG Laser Vitreolysis for Symptomatic Vitreous Floaters (VVF)

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 Overview

• Status: Recruiting
• Conditions: Weiss Ring
• Intervention / Treatment: Procedure: YAG vitreolysis

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hangshuai Zhou; Phone Number: +8618867940019; Email: 350589935@qq.com

Study Locations

• China
  • Zhejiang
    • Dongyang, Zhejiang, China, 322100
      • Recruiting
      • Dongyang People's Hospital
      • Contact: Hangshuai Zhou; Phone Number: +8618867940019; Email: 350589935@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. 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.
3. Able to position for the YAG laser procedure.
4. 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.
5. Willing and able to comply with clinic visits and study-related procedures
6. If the patient has two symptomatic eyes, only one eye can be randomized and included in the study.
7. Provide signed informed consent

Exclusion Criteria:

1. History of retinal tear, retinal detachment, or uveitis in the study eye
2. History of diabetic retinopathy, macular edema, retinal vein occlusion, or aphakia in the study eye
3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: early treatment group; Participants in the early treatment group will receive a YAG laser vitreolysis immediately and a sham laser treatment three months later.	Procedure: 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.; Other Names: Sham YAG vitreolysis
Experimental: delayed treatment group; Participants in the delayed treatment group will receive a sham laser treatment immediately and a YAG laser vitreolysis three months late.	Procedure: 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.; Other Names: Sham YAG vitreolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?	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.	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 Months

Collaborators and Investigators

• Sponsor: Dongyang People's Hospital
• Investigators: Study Chair: Guangjin Zhao, Dongyang People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 20, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Nd:YAG laser; Vitreous floaters; vitreolysis
• Other Study ID Numbers: DongyangPH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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