Clear Vision Study

Posterior Vitreous Detachment Clinical Trial

Official title:

Randomized Trial of Laser Ablation for Highly Symptomatic Floaters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970267
• Other study ID #: H13-01836
• Status: Completed
• Phase: N/A
• First received: October 22, 2013
• Last updated: April 20, 2016
• Start date: October 2013
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posterior Vitreous Detachment
• Vitreous Detachment
• Vitreous Floaters

Intervention

Procedure:
• Laser Ablation of Floaters

• 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.

Locations

Country	Name	City	State
Canada	Eye Care Centre, Vancouver General Hospital	Vancouver	British Columbia
Canada	West Coast Retina Consultants Clinic	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Number of complications in the laser treated eyes compared to the non-treated eyes		6 months	Yes