Clear Vision Study

N/ACompletedNCT01970267

University of British Columbia35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Posterior Vitreous Detachment Vitreous Floaters

Interventions

Laser Ablation of FloatersPROCEDURE

Sham Laser TreatmentPROCEDURE

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (2)

West Coast Retina Consultants Clinic

Vancouver, British Columbia, Canada

Eye Care Centre, Vancouver General Hospital

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Efficacy of the laser treatment measured by the improvement of visual acuity and floater specific Visual Function Questionnaire (VFQ).

Time frame: after the last treatment session (approximately 5 days)

Secondary Outcomes

Number of complications in the laser treated eyes compared to the non-treated eyes

Time frame: 6 months

Data from ClinicalTrials.gov

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