GlaucomaPhase 3SLTRepeatNCT01687465

A Trial to Compare the Laser Treatment (SLT vs. ALT) in Glaucoma Patients

A Phase 3 study testing Argon laser trabeculoplasty and Selective laser trabeculoplasty in people with Glaucoma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 7 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
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: 139 participants
Where: 7 sitesCanada
Study dates: Nov 2012to Mar 2018
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Over age of 18 yo.
OAG including pigmentary dispersion syndrome and pseudoexfoliation
OAG has been treated with 360 degrees of SLT
two sighted eyes,
willing to participate after being informed of and reading the patient information material.

Who cannot join

Narrow angle glaucoma
Previous glaucoma surgery
Eye surgery expected in the next 12 months
Severe corneal disease
On or anticipated steroid in 6 months
Pregnant or breast feeding

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Canada7 sites

Rockyview General Hospital, University of Calgary
Calgary, Alberta, T3E 7M8
Royal Alexandra Hospital, University of Alberta
Edmonton, Alberta, T5H 3V9
Eye Care Centre, Dalhousie University
Halifax, Nova Scotia, B3H2R1
McMaser University, St. Joseph's Healthcare Hamilton, CAHS Regional Eye Institute
Hamilton, Ontario, L8G 5E4
Ivey Eye Institute, St. Joseph's Hospital, Western University
London, Ontario, N6A 4V2
McGill University, Dept. of Ophthalmology, Royal Victoria Hospital,
Montreal, Quebec, H3A 1A1
Sunnybrook Health Sciences Centre, University of Toronto
Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: A Randomized Clinical Trial of Selective Laser Trabeculoplasty (SLT) in Open Angle Glaucoma Who Had Been Previously Treated With Complete SLT

Lasers are important therapy in glaucoma. They are a pivotal point in treatment between medical and surgical care. Over the last 10 years a new laser has emerged as the usual laser treatment: Selective laser trabeculoplasty (SLT). SLT works as well as the older laser used: argon laser trabeculoplasty (ALT). However SLT has many theoretical benefits over ALT including causing less damage to the tissue it affects. One of the potential patient centered benefits of this laser is that it may be repeatable. It is even possible that the old laser ALT may be useable after an SLT treatment. This study aims to uncover whether repeat laser is possible after SLT and if so which laser is more effective (ALT vs SLT). The potential of repeating laser therapies may delay surgical treatment and its complications. Also understanding which laser to use will help eye doctors know how to treat their patients at this point of the disease.

Conditions: Glaucoma
Being tested: Argon laser trabeculoplasty, Selective laser trabeculoplasty
Keywords: glaucoma, laser, SLT, ALT
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
With Argon laser trabeculoplasty (ALT), thermal energy is used directed towards the Trabecular Meshwork (the site of aqueous drainage from the eye),which causes focal scarring of trabecular meshwork, thus enable fluid drainage more effectively. However, this procedure may not be repeatable since it causes too much damage to the trabecular meshwork.
Selective laser trabeculoplastyProcedure or surgery
Selective laser trabeculoplasty is a relatively newer technology that uses a Nd:YAG laser to target specific cells within the trabecular meshwork. SLT does not cause coagulative damage to the trabecular meshwork, and thus has the advantage of being repeatable.

Study groups in NCT01687465
Study group	Role	What they receive
Argon laser trabeculoplasty	Active comparator	Up to the year 2005, the vast majority of ophthalmologists used Argon laser trabeculoplasty (ALT) as the mode of laser therapy. ALT is effective but its most significant problem is that its effectiveness decreases with re-treatment since the tissue it targets (the trabecular meshwork) is changed by the laser rendering repeat treatments less effective. Receives: Procedure: Argon laser trabeculoplasty; Procedure: Selective laser trabeculoplasty
selective laser trabeculoplasty	Active comparator	Post 2005, a newer mode of laser therapy, selective laser trabeculoplasty (SLT) has emerged as the standard of care laser. There are many potential advantages to SLT but to date these advantages are only theoretical. The most important potential clinical advantage of SLT is that it causes less damage to the tissue it targets. Receives: Procedure: Argon laser trabeculoplasty; Procedure: Selective laser trabeculoplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

Intraocular Pressure
IOP difference between baseline and 12 month post-laser.
Measured: 12 months post operatively

Secondary outcomes (5)

To compare the IOP lowering effect between the groups at other postoperative visits
IOP difference between baseline, 1hr, 1 wk, and 1, 3, 6 and 12 mon post-laser.
Measured: 12 months
To compare the visual acuity between the groups at all visits.
VA difference between baseline, 1hr, 1 wk, and 1, 3, 6 and 12 mon post-laser.
Measured: 12 months
To compare the trabecular meshwork pigmentation between the groups at all visits.
Measured: 12 months
To compare any adverse events between the two groups at all visits.
Measured: 12 months
SLT repeatability of long term follow up in glaucoma patients
The follow up time has been extended two more years. Patients will be followed up Q6 months.
Measured: 36 months after initial enrollment of the primary study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Mar 2018

First posted19 Sep 2012 (estimated)
Study startNov 2012
Primary completionMar 2018 (estimated)
Study completionMar 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for GlaucomaStudies of the same condition, open and under way.
More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01687465
Sponsor's protocol ID: CIHR granted glaucoma RCT
Acronym: SLTRepeat
Status last verified: Mar 2018
First submitted: 11 Sep 2012
Last updated: 6 Mar 2018
Results posted: No
Data monitoring committee: Yes

Publications

Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
PubMed 35943114
Hutnik C, Crichton A, Ford B, Nicolela M, Shuba L, Birt C, Sogbesan E, Damji KF, Dorey M, Saheb H, Klar N, Guo H, Hodge W. Selective Laser Trabeculoplasty versus Argon Laser Trabeculoplasty in Glaucoma Patients Treated Previously with 360 degrees Selective Laser Trabeculoplasty: A Randomized, Single-Blind, Equivalence Clinical Trial. Ophthalmology. 2019 Feb;126(2):223-232. doi: 10.1016/j.ophtha.2018.09.037. Epub 2018 Sep 29.
PubMed 30278197

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)

All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Clinical Trial of Selective Laser Trabeculoplasty (SLT) in Open Angle Glaucoma Who Had Been Previously Treated With Complete SLT
ClinicalTrials.gov ID: NCT01687465
Acronym / sponsor ID: SLTRepeat / CIHR granted glaucoma RCT
Conditions: Glaucoma
Keywords: glaucoma, laser, SLT, ALT
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 139 participants (actual)
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
Study start: Nov 2012
Primary completion: Mar 2018 (estimated)
Study completion: Mar 2018 (estimated)
First posted: 19 Sep 2012 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Argon laser trabeculoplasty	Active comparator	Procedure: Argon laser trabeculoplasty, Procedure: Selective laser trabeculoplastyUp to the year 2005, the vast majority of ophthalmologists used Argon laser trabeculoplasty (ALT) as the mode of laser therapy. ALT is effective but its most significant problem is that its effectiveness decreases with re-treatment since the tissue it targets (the trabecular meshwork) is changed by the laser rendering repeat treatments less effective.
selective laser trabeculoplasty	Active comparator	Procedure: Argon laser trabeculoplasty, Procedure: Selective laser trabeculoplastyPost 2005, a newer mode of laser therapy, selective laser trabeculoplasty (SLT) has emerged as the standard of care laser. There are many potential advantages to SLT but to date these advantages are only theoretical. The most important potential clinical advantage of SLT is that it causes less damage to the tissue it targets.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Over age of 18 yo.
OAG including pigmentary dispersion syndrome and pseudoexfoliation
OAG has been treated with 360 degrees of SLT
two sighted eyes,
willing to participate after being informed of and reading the patient information material.

Key exclusion criteria (6 listed)

Narrow angle glaucoma
Previous glaucoma surgery
Eye surgery expected in the next 12 months
Severe corneal disease
On or anticipated steroid in 6 months

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 trabeculoplastyWith Argon laser trabeculoplasty (ALT), thermal energy is used directed towards the Trabecular Meshwork (the site of aqueous drainage from the eye),which causes focal scarring of trabecular meshwork, thus enable fluid drainage more effectively. However, this procedure may not be repeatable since it causes too much damage to the trabecular meshwork.	Procedure or surgery	Argon laser trabeculoplasty, selective laser trabeculoplasty
Selective laser trabeculoplastySelective laser trabeculoplasty is a relatively newer technology that uses a Nd:YAG laser to target specific cells within the trabecular meshwork. SLT does not cause coagulative damage to the trabecular meshwork, and thus has the advantage of being repeatable.	Procedure or surgery	Argon laser trabeculoplasty, selective laser trabeculoplasty

Primary outcome

Intraocular Pressure
Time frame: 12 months post operatively
IOP difference between baseline and 12 month post-laser.

5 secondary outcomes

To compare the IOP lowering effect between the groups at other postoperative visits
Time frame: 12 months
To compare the visual acuity between the groups at all visits.
Time frame: 12 months
To compare the trabecular meshwork pigmentation between the groups at all visits.
Time frame: 12 months
To compare any adverse events between the two groups at all visits.
Time frame: 12 months
SLT repeatability of long term follow up in glaucoma patients
Time frame: 36 months after initial enrollment of the primary study

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
Derived from this study: PubMed 35943114Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
Derived from this study: PubMed 30278197Hutnik C, Crichton A, Ford B, Nicolela M, Shuba L, Birt C, Sogbesan E, Damji KF, Dorey M, Saheb H, Klar N, Guo H, Hodge W. Selective Laser Trabeculoplasty versus Argon Laser Trabeculoplasty in Glaucoma Patients Treated Previously with 360 degrees Selective Laser Trabeculoplasty: A Randomized, Single-Blind, Equivalence Clinical Trial. Ophthalmology. 2019 Feb;126(2):223-232. doi: 10.1016/j.ophtha.2018.09.037. Epub 2018 Sep 29.

Related trials for Glaucoma

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)

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.

William G Hodge, MD, PhD principal investigator

Lawson Research Institute, Univ. of Western Ontario

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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: status not confirmed, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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: 12 months post operatively). 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 NCT01687465, which also lists 2 linked publications.

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 6 Mar 2018.