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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

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

NCT ID

NCT01970267

First Posted

October 22, 2013

Last Updated

April 20, 2016

Sponsor

University of British Columbia

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

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

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

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

Learn more about this trial

Clear Vision Study

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