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

Dongyang People's Hospital

Status: Enrolling

Conditions: Weiss Ring

Treatments: Procedure: YAG vitreolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT05800353

DongyangPH

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

early treatment group

Experimental group

Description:

Participants in the early treatment group will receive a YAG laser vitreolysis immediately and a sham laser treatment three months later.

Treatment:

Procedure: YAG vitreolysis

delayed treatment group

Experimental group

Description:

Participants in the delayed treatment group will receive a sham laser treatment immediately and a YAG laser vitreolysis three months late.

Treatment:

Procedure: YAG vitreolysis