Clear Vision Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Posterior Vitreous Detachment Eye Diseases Vitreous Detachment Vitreous Floaters

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Care Centre, Vancouver General Hospital, Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser Ablation of Floaters

Procedure

Sham Laser Treatment

Procedure

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.

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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Randomized Trial of Laser Ablation for Highly Symptomatic Floaters

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Oct 28, 2013
Registry last updated: Apr 21, 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.

Published trials that share one or more normalized conditions with this study.

Completed