YAG Vitreolysis for Floaters

Not Applicable

Completed

• Conditions: Floaters; Weiss Ring; Posterior Vitreous Detachment
• Interventions: Procedure: YAG vitreolysis

• Registration Number: NCT02897583
• Lead Sponsor: Ophthalmic Consultants of Boston

Brief Summary

This is a single-center, prospective randomized controlled trial evaluating the safety and efficacy of YAG vitreolysis versus sham for symptomatic Weiss ring due to posterior vitreous detachment.

Detailed Description

52 subjects will be enrolled in the trial and randomized in a 2:1 ratio to receive either YAG laser vitreolysis or sham laser for symptomatic Weiss ring due to posterior vitreous detachment. Subjects will follow up at one week, one month, three months, and six months after the procedure. Assessments will include a questionnaire regarding duration of floater symptoms prior to presentation, severity of floater symptoms, number of floaters, and activity most inconvenienced by presence of floaters; Medical, ocular history and demographics collected; ETDRS and Snellen visual acuity; Optos color photography; Heidelberg Spectralis Optical Coherence Tomography (OCT) and infrared photo; B scan ultrasound of Weiss ring with caliper measurement of nearest distance between Weiss ring and retina, Weiss ring and posterior lens capsule (only in phakic eyes); Slit lamp and indirect ophthalmoscopy with scleral depression of study eye; Applanation tonometry; Visual Functioning Questionnaire-25 (VFQ 25). Qualitative change in Optos photography will evaluated by a masked physician.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-06-16
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-12
• Last Update Submitted: 2016-09-12
• Study First Posted: 2016-09-13
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. Symptoms of floaters that correlate to the presence of a posterior vitreous detachment for at least 6 months
2. Documented posterior vitreous detachment on clinical examination, OCT, and B scan
3. 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.
4. Symptomatic Weiss ring (PVD) must be at least 3 mm 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.
5. Able to position for the YAG laser procedure.
6. 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.
7. Willing and able to comply with clinic visits and study-related procedures
8. If the patient has two symptomatic eyes, only one eye can be randomized and included in the study.
9. Provide signed informed consent

Exclusion Criteria

1. Snellen best corrected visual acuity worse than 20/50 in the fellow eye
2. History of retinal tear, retinal detachment, or uveitis in the study eye
3. History of diabetic retinopathy, macular edema, retinal vein occlusion, or aphakia in the study eye
4. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham YAG vitreolysis	YAG vitreolysis	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.
YAG vitreolysis	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. Only one treatment session will be performed.

Primary Outcome Measures

Name	Time	Method
Subjective improvement in floater symptoms	6 Months	Questionnaire which asks: "Please rate your visual disturbance by the floaters on a 0-10 scale, with 0 being no symptoms to 10 being debilitating symptoms," "Please quantify your post-operative improvement as a percentage," and "How would you describe your floaters today compared to right before the laser procedure?"

Secondary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	6 Months	Mean change in visual acuity from Baseline as measured by ETDRS vision testing at 6 months
VFQ-25 Near Activities	6 Months	Mean change in baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) near activities subscale
VFQ-25 Distance Activities	6 Months	Mean change in baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) distance activities subscale
Qualitative changes on infrared and color photography	6 Months	Qualitative changes on infrared and color photography
Incidence and severity of ocular and systemic adverse events	6 Months	Incidence and severity of ocular and systemic adverse events