Clear Vision Study

Not Applicable

Completed

• Conditions: Vitreous Floaters; Posterior Vitreous Detachment
• Interventions: Procedure: Sham Laser Treatment; Procedure: Laser Ablation of Floaters

• Registration Number: NCT01970267
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-25
• Study First Posted: 2013-10-28
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Not Treated	Sham Laser Treatment	-
Laser Treated	Laser Ablation of Floaters	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of complications in the laser treated eyes compared to the non-treated eyes	6 months

Trial Locations

Locations (2)

Eye Care Centre, Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

West Coast Retina Consultants Clinic; 🇨🇦 Vancouver, British Columbia, Canada