Clinical trial NCT05800353: Nd:YAG Laser Vitreolysis for Symptomatic Vitreous Floaters
Official title: Nd:YAG Laser Vitreolysis for Symptomatic Vitreous Floaters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weiss Ring
Keywords: Vitreous floaters
vitreolysis
Nd:YAG laser
Lead sponsor: Dongyang People's Hospital
Sponsor class: OTHER_GOV
First posted: 2023-04-05
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Subjective improvement in floater symptoms
timeFrame: 3 Months
measure: Visual Functioning Questionnaire-25
timeFrame: 3 Months
Secondary outcomes:
measure: Qualitative changes through OCT and fundus photography
timeFrame: 3 Months
measure: Incidence and severity of ocular and systemic adverse events
timeFrame: 3 Months
Other outcomes:
Locations:
city: Dongyang
country: China
facility: Dongyang People's Hospital
state: Zhejiang
Study officials:
affiliation: Dongyang People's Hospital
name: Guangjin Zhao
role: STUDY_CHAIR
References: