Clear Vision Study

NCT01970267 | Completed

• 1 other identifier: H13-01836
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of complications in the laser treated eyes compared to the non-treated eyes

  6 months

Study Arms (2)

Laser Treated

ACTIVE COMPARATOR

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

Procedure: Laser Ablation of Floaters

Not Treated

SHAM COMPARATOR

Procedure: Sham Laser Treatment

Interventions

Laser Ablation of Floaters PROCEDURE

Laser Treated

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.

Not Treated

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (2)

West Coast Retina Consultants Clinic

Vancouver, British Columbia, V5Z 1K1, Canada

Location

Eye Care Centre, Vancouver General Hospital

Vancouver, British Columbia, V5Z 3N9, Canada

Location

MeSH Terms

Conditions

Vitreous Detachment; vitreous floaters

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Andrew B Merkur, MD

  University of British Columbia

  STUDY CHAIR

• Mei Young, MASc

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: October 28, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 21, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)