Clinical trial NCT01970267: Clear Vision Study
Official title: Randomized Trial of Laser Ablation for Highly Symptomatic Floaters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Vitreous Detachment
Vitreous Floaters
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-10-28
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of the laser treatment measured by the improvement of visual acuity and floater specific Visual Function Questionnaire (VFQ).
timeFrame: after the last treatment session (approximately 5 days)
Secondary outcomes:
measure: Number of complications in the laser treated eyes compared to the non-treated eyes
timeFrame: 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: West Coast Retina Consultants Clinic
state: British Columbia
city: Vancouver
country: Canada
facility: Eye Care Centre, Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Andrew B Merkur, MD
role: STUDY_CHAIR
affiliation: University of British Columbia
name: Mei Young, MASc
role: STUDY_DIRECTOR
References: