Posterior Vitreous DetachmentNCT01970267
Clear Vision Study
A study testing Laser Ablation of Floaters in people with Posterior Vitreous Detachment and Vitreous Floaters, run by University of British Columbia at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Posterior Vitreous Detachment, Vitreous Floaters
- What is being tested?
- Laser Ablation of Floaters
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2013to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
West Coast Retina Consultants Clinic
Vancouver, British Columbia, V5Z 1K1
Eye Care Centre, Vancouver General Hospital
Vancouver, British Columbia, V5Z 3N9
About this study
Official title: Randomized Trial of Laser Ablation for Highly Symptomatic Floaters
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
- Being tested
- Laser Ablation of Floaters, Sham Laser Treatment
- Medical subject headings
- Vitreous Detachment, vitreous floaters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Ablation of FloatersProcedure or surgery
Sham Laser TreatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Laser Ablation of Floaters |
| Not Treated | Sham comparator | Not described Receives: Procedure: Sham Laser Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the laser treatment measured by the improvement of visual acuity and floater specific Visual Function Questionnaire (VFQ).
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Vitreous DetachmentStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew B Merkur, MD, Study chair, University of British ColumbiaMei Young, MASc, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970267
- Sponsor's protocol ID
- H13-01836
- Status last verified
- Apr 2016
- First submitted
- 22 Oct 2013
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Laser Ablation for Highly Symptomatic Floaters
- ClinicalTrials.gov ID
- NCT01970267
- Acronym / sponsor ID
- H13-01836
- Conditions
- Posterior Vitreous Detachment, Vitreous Floaters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 28 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Treated | Active comparator | Procedure: Laser Ablation of FloatersLaser 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 |
| Not Treated | Sham comparator | Procedure: Sham Laser Treatment |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser Ablation of Floaters | Procedure or surgery | Laser Treated |
| Sham Laser TreatmentLaser 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. | Procedure or surgery | Not Treated |
Primary outcome
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)
1 secondary outcome
Number of complications in the laser treated eyes compared to the non-treated eyes
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Posterior Vitreous Detachment
RecruitingObservational study
Quantification & Classification of Inflammatory Cells in Uveitis Using OCT
Anterior Uveitis (AU), Birdshot Chorioretinitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew B Merkur, MD study chair
University of British Columbia
Mei Young, MASc study director
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Ablation of Floaters in people with Posterior Vitreous Detachment and Vitreous Floaters, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.