Posterior Vitreous Detachment, Vitreous Floaters
Conditions
Brief summary
Vitreous floaters are tiny, cloudy, clumps of cells that appear in the otherwise clear fluid (vitreous) that fills the back 3/4 of the eye. Floaters are commonly caused by eye conditions such as posterior vitreous detachment (PVD), vitreous syneresis and asteroid hyalosis. While these symptoms are considered physiological in nature, they can be of considerable inconvenience to many patients which affect essential activities. The investigators wish to assess the safety and efficacy of floater treatment in patients with highly symptomatic floaters using an FDA approved nanosecond infrared yttrium aluminum garnet (YAG) lasers.
Interventions
PROCEDURELaser Ablation of Floaters
PROCEDURESham Laser Treatment
Laser will be set at 0.3 millijoules (mJ). There will be a 100% absorptive filter (black spot) of about 1cm placed centrally on the lens. All laser aiming beams will be placed within the 1cm filter. Laser will be applied at 0.3 mJ at the absorptive black spot (100% density filter) in order to create a realistic treatment therapy procedure.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have been diagnosed with symptomatic floaters lasting more than 2 months * Willing to proceed with intervention * Be able to provide informed consent * Diagnosed with Posterior Vitreous Detachment * Accept a 1% risk of complications
Exclusion criteria
* Less than 19 years of age * Is a high myope (greater than -6 diopters) * Has monocular vision * Diagnosed with asteroid hyalosis * Diagnosed with acute on-set of floaters (less than two months and may clear spontaneously) * Has corneal or lenticular opacities or any media opacity which may interfere with treatment * Has any concomitant ocular disease or pathology * Has elevated intraocular pressure (IOP) or on IOP lowering medication * Has floaters that are deemed to require more than five treatment sessions, where surgical intervention is the best treatment course * Has floaters inaccessible with current lasers and lenses * Has floaters located less than 2mm from the crystalline lens or the retina * Found to have retinal tears or retinal detachment on initial examination or has had a history of retinal detachment repair within the last two years * Has psychiatric problems that may recur or worsen * Incapacity to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of the laser treatment measured by the improvement of visual acuity and floater specific Visual Function Questionnaire (VFQ). | after the last treatment session (approximately 5 days) |
Secondary
| Measure | Time frame |
|---|---|
| Number of complications in the laser treated eyes compared to the non-treated eyes | 6 months |
Countries
Canada
Outcome results
None listed