Clear Vision Study

NCT ID: NCT01970267

Last Updated: 2016-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-02-29

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.

Conditions

Posterior Vitreous Detachment; Vitreous Floaters

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Laser Treated

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

Group Type: ACTIVE_COMPARATOR

Laser Ablation of Floaters

Intervention Type: PROCEDURE

Not Treated

Group Type: SHAM_COMPARATOR

Sham Laser Treatment

Intervention Type: 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.

Interventions

Laser Ablation of Floaters

Intervention Type: PROCEDURE

Sham Laser Treatment

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew B Merkur, MD

Role: STUDY_CHAIR

University of British Columbia

Mei Young, MASc

Role: STUDY_DIRECTOR

University of British Columbia

Locations

West Coast Retina Consultants Clinic

Vancouver, British Columbia, Canada

Eye Care Centre, Vancouver General Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H13-01836

Identifier Type: -

Identifier Source: org_study_id