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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
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.
Dongyang People's Hospital
Dongyang, Zhejiang, China
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?
Time frame: 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.
Time frame: 3 Months
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.
Time frame: 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.
Time frame: 3 Months
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