GlaucomaNCT01087684
Response to SLT vs. ALT in Patients Under 60 Years of Age
A study testing Argon laser trabeculoplasty and Selective laser trabeculoplasty in people with Glaucoma, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Laser trabeculoplasty is a routine treatment for glaucoma and can be performed with either argon (ALT) or selective Yag (SLT) lasers. The effectiveness of each has not been studied in patients under 60 years, which is younger than average for the procedure. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Argon laser trabeculoplasty and Selective laser trabeculoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2004to Dec 2008
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age < 60 years
- Intraocular pressure not adequately controlled
Who cannot join
- Prior laser treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Clinically Based Study on the Response to Selective Laser Trabeculoplasty Versus Argon Laser Trabeculoplasty in Patients Who Are Under 60 Years of Age
Laser trabeculoplasty is a routine treatment for glaucoma and can be performed with either argon (ALT) or selective Yag (SLT) lasers. The effectiveness of each has not been studied in patients under 60 years, which is younger than average for the procedure. The study hypothesis is that there will be no difference between the two laser types.
Read the detailed description
Forty-two young patients (age 29 to 60) had one eye randomized to ALT (n = 22) or SLT (n = 20). Intraocular pressure was measured prior to laser and 1 hour, 1 day, 6 weeks, 3 months, every 3 months until 2 years, and then yearly post-laser. χ2 analysis and student's t-test were used to determine statistical significance.
- Conditions
- Glaucoma
- Being tested
- Argon laser trabeculoplasty, Selective laser trabeculoplasty
- Keywords
- Glaucoma, laser trabeculoplasty, intraocular pressure
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argon laser trabeculoplastyProcedure or surgery
Also called ALT
Argon laser 600-800 mW, 0.1seconds, 50 micron spot size, 45 - 55 burns over 180 degrees of trabecular meshwork
Selective laser trabeculoplastyProcedure or surgery
Also called SLT
Selective laser trabeculoplasty 0.7 - 0.8 mJ, 400 micron spot size, 3 nanosecond, 45 - 55 burns over 180 degrees of trabecular meshwork.
| Study group | Role | What they receive |
|---|---|---|
| Argon laser trabeculoplasty | Active comparator | Patients received standard argon laser treatment Receives: Procedure: Argon laser trabeculoplasty |
| Selective laser trabeculoplasty | Active comparator | Patients received a standard selective laser treatment Receives: Procedure: Selective laser trabeculoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
The intraocular pressure was measured at 6 weeks, 4.5 months, 9, 12, 18 and 24 months following the laser treatment.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startDec 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Catherine Birt, Sunnybrook Health Sciences Centre
- Investigators
- Catherine M Birt, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087684
- Sponsor's protocol ID
- 459-2004
- Status last verified
- Oct 2013
- First submitted
- 15 Mar 2010
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu Y, Birt CM. Argon versus selective laser trabeculoplasty in younger patients: 2-year results. J Glaucoma. 2012 Feb;21(2):112-5. doi: 10.1097/IJG.0b013e318202791c.
PubMed 21572334
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Clinically Based Study on the Response to Selective Laser Trabeculoplasty Versus Argon Laser Trabeculoplasty in Patients Who Are Under 60 Years of Age
- ClinicalTrials.gov ID
- NCT01087684
- Acronym / sponsor ID
- 459-2004
- Conditions
- Glaucoma
- Keywords
- Glaucoma, laser trabeculoplasty, intraocular pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Mar 2010 (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.
Laser trabeculoplasty is a routine treatment for glaucoma and can be performed with either argon (ALT) or selective Yag (SLT) lasers. The effectiveness of each has not been studied in patients under 60 years, which is younger than average for the procedure. The study hypothesis is that there will be no difference between the two laser types.
Detailed description
Forty-two young patients (age 29 to 60) had one eye randomized to ALT (n = 22) or SLT (n = 20). Intraocular pressure was measured prior to laser and 1 hour, 1 day, 6 weeks, 3 months, every 3 months until 2 years, and then yearly post-laser. χ2 analysis and student's t-test were used to determine statistical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Argon laser trabeculoplasty | Active comparator | Procedure: Argon laser trabeculoplastyPatients received standard argon laser treatment |
| Selective laser trabeculoplasty | Active comparator | Procedure: Selective laser trabeculoplastyPatients received a standard selective laser treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age < 60 years
- Intraocular pressure not adequately controlled
Key exclusion criteria (1 listed)
- Prior laser treatment
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 |
|---|---|---|
| Argon laser trabeculoplastyAlso: ALTArgon laser 600-800 mW, 0.1seconds, 50 micron spot size, 45 - 55 burns over 180 degrees of trabecular meshwork | Procedure or surgery | Argon laser trabeculoplasty |
| Selective laser trabeculoplastyAlso: SLTSelective laser trabeculoplasty 0.7 - 0.8 mJ, 400 micron spot size, 3 nanosecond, 45 - 55 burns over 180 degrees of trabecular meshwork. | Procedure or surgery | Selective laser trabeculoplasty |
Primary outcome
Intraocular pressure
Time frame: Two years
The intraocular pressure was measured at 6 weeks, 4.5 months, 9, 12, 18 and 24 months following the laser treatment.
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 10 Oct 2013.
- Results publication: PubMed 21572334Liu Y, Birt CM. Argon versus selective laser trabeculoplasty in younger patients: 2-year results. J Glaucoma. 2012 Feb;21(2):112-5. doi: 10.1097/IJG.0b013e318202791c.
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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.
Catherine M Birt, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Argon laser trabeculoplasty and Selective laser trabeculoplasty in people with Glaucoma, run by Sunnybrook Health Sciences Centre at 1 site 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 2 inclusion and 1 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 10 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Intraocular pressure (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01087684, which also lists 1 linked publication.
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 10 Oct 2013.