Clinical trial NCT02897583: YAG Vitreolysis for Floaters
Official title: A Prospective Randomized Controlled Trial Evaluating the Safety and Efficacy of YAG Vitreolysis Versus Sham for Symptomatic Weiss Ring Due to Posterior Vitreous Detachment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weiss Ring
Floaters
Posterior Vitreous Detachment
Lead sponsor: Ophthalmic Consultants of Boston
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjective improvement in floater symptoms
timeFrame: 6 Months
Secondary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: 6 Months
measure: VFQ-25 Near Activities
timeFrame: 6 Months
measure: VFQ-25 Distance Activities
timeFrame: 6 Months
measure: Qualitative changes on infrared and color photography
timeFrame: 6 Months
measure: Incidence and severity of ocular and systemic adverse events
timeFrame: 6 Months
Other outcomes:
Locations:
Study officials:
affiliation: Attending Physician
name: Chirag P Shah, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah CP, Heier JS. YAG Laser Vitreolysis vs Sham YAG Vitreolysis for Symptomatic Vitreous Floaters: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Sep 1;135(9):918-923. doi: 10.1001/jamaophthalmol.2017.2388.