Clear Vision Study

University of British Columbia

Status: Completed

Conditions: Vitreous Floaters; Posterior Vitreous Detachment

Treatments: Procedure: Sham Laser Treatment; Procedure: Laser Ablation of Floaters

Study type: Interventional

Funder types: Other

Identifiers

NCT01970267

H13-01836

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Laser Treated

Active Comparator group

Description:

Laser will direct the laser at vitreous opacities. The power of the laser will be adjusted from 0.3-12 millijoules (mJ) with the end point being laser induced optical breakdown and the production of a small gas bubble 50% of the time. The treatment will attempt to reduced or eliminate symptomatic floaters in the visual axis. Each treatment session will be limited to 300 laser applications. Participants will be retreated based on continued symptoms for up to 5 sessions

Treatment:

Procedure: Laser Ablation of Floaters

Not Treated

Sham Comparator group

Treatment:

Procedure: Sham Laser Treatment