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Clear Vision Study

Primary Purpose

Posterior Vitreous Detachment, Vitreous Floaters

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Laser Ablation of Floaters
Sham Laser Treatment
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posterior Vitreous Detachment

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • West Coast Retina Consultants Clinic
  • Eye Care Centre, Vancouver General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Laser Treated

Not Treated

Arm 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

Outcomes

Primary Outcome Measures

Efficacy of the laser treatment measured by the improvement of visual acuity and floater specific Visual Function Questionnaire (VFQ).

Secondary Outcome Measures

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

Full Information

First Posted
October 22, 2013
Last Updated
April 20, 2016
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01970267
Brief Title
Clear Vision Study
Official Title
Randomized Trial of Laser Ablation for Highly Symptomatic Floaters
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Vitreous Detachment, Vitreous Floaters

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser Treated
Arm Type
Active Comparator
Arm 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
Arm Title
Not Treated
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Laser Ablation of Floaters
Intervention Type
Procedure
Intervention Name(s)
Sham Laser Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of the laser treatment measured by the improvement of visual acuity and floater specific Visual Function Questionnaire (VFQ).
Time Frame
after the last treatment session (approximately 5 days)
Secondary Outcome Measure Information:
Title
Number of complications in the laser treated eyes compared to the non-treated eyes
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew B Merkur, MD
Organizational Affiliation
University of British Columbia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mei Young, MASc
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
West Coast Retina Consultants Clinic
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1K1
Country
Canada
Facility Name
Eye Care Centre, Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3N9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Clear Vision Study

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