NCT Number: NCT02897583
YAG Vitreolysis for Floaters
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.
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Conditions
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Symptoms of floaters that correlate to the presence of a posterior vitreous detachment for at least 6 months
- Documented posterior vitreous detachment on clinical examination, OCT, and B scan
- 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.
- 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.
- Able to position for the YAG laser procedure.
- 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.
- Willing and able to comply with clinic visits and study-related procedures
- If the patient has two symptomatic eyes, only one eye can be randomized and included in the study.
- Provide signed informed consent
Exclusion criteria
- Snellen best corrected visual acuity worse than 20/50 in the fellow eye
- History of retinal tear, retinal detachment, or uveitis in the study eye
- History of diabetic retinopathy, macular edema, retinal vein occlusion, or aphakia in the study eye
- 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
Treatment and study plan
Primary outcomes
-
Subjective improvement in floater symptoms
Time frame: 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 outcomes
-
Best Corrected Visual Acuity
Time frame: 6 Months
Mean change in visual acuity from Baseline as measured by ETDRS vision testing at 6 months
-
VFQ-25 Near Activities
Time frame: 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
Time frame: 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
Time frame: 6 Months
Qualitative changes on infrared and color photography
-
Incidence and severity of ocular and systemic adverse events
Time frame: 6 Months
Incidence and severity of ocular and systemic adverse events
Sponsors and collaborators
Lead sponsor
Ophthalmic Consultants of Boston
Other
Registry information
Official study 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
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Sep 13, 2016
- Registry last updated
- Sep 13, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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