GlaucomaPhase 3NCT00551395
Timing of Treatment Completion in Staged Selective Laser Trabeculoplasty (SLT): Early vs. Late Completion
A Phase 3 study testing selective laser trabeculoplasty - early completion and Selective laser trabeculoplasty - late completion in people with Glaucoma, run by Queen's University at 1 site in Canada.
Trial summary
This study will evaluate the effect of the timing of treatment completion in two-staged selective laser trabeculoplasty therapy on intraocular pressure lowering effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- selective laser trabeculoplasty - early completion and Selective laser trabeculoplasty - late completion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Jan 2009
- 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
- 18 years of age
- primary open angle glaucoma or pseudoexfoliation glaucoma
Who cannot join
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hotel Dieu Hospital & Queen's University
Kingston, Ontario, K7L 5G2
About this study
This study will evaluate the effect of the timing of treatment completion in two-staged selective laser trabeculoplasty therapy on intraocular pressure lowering effect.
Read the detailed description
SLT therapy is used as an IOP lowering agent in patients with glaucoma. It is unknown whether the timing of a 2-staged approach to the laser therapy will result in better IOP lowering effect.
This study will evaluate the timing (early vs. late completion of SLT therapy) and determined the IOP lowering effect following the interventions.
Arm 1: Early Completion SLT
180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees on Day 2
Arm 2: Late Completion SLT
180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees at the 1 month follow up visit.
Primary Outcome: IOP (mmHg).
- Conditions
- Glaucoma
- Being tested
- selective laser trabeculoplasty - early completion, Selective laser trabeculoplasty - late completion
- Keywords
- glaucoma, laser, trabeculoplasty
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective laser trabeculoplasty - early completionProcedure or surgery
180 degrees of laser on day 1 and other 180 degrees on day 2.
Selective laser trabeculoplasty - late completionProcedure or surgery
180 degrees of laser on day 1 and other 180 degrees at 1 month follow up point.
| Study group | Role | What they receive |
|---|---|---|
| SLT Early Completion (Arm 1) | Experimental | Intervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degree on Day 2 Receives: Procedure: selective laser trabeculoplasty - early completion |
| SLT Late Completion (Arm 2) | Active comparator | Intervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degrees at 1 month follow up appointment. Receives: Procedure: Selective laser trabeculoplasty - late completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure lowering
Measured: 1 month following procedure
Secondary outcomes (1)
intraocular pressure lowering
Measured: 3, 6, 12 and 24 months following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Poor recruitment
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.
- 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
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Robert Campbell, Queen's University
- Investigators
- Robert J Campbell, MD, Principal investigator, Queen's University, Kingston, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551395
- Sponsor's protocol ID
- RC-1
- Status last verified
- Sep 2015
- First submitted
- 29 Oct 2007
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Treatment Completion in Staged Selective Laser Trabeculoplasty (SLT): Early vs. Late Completion
- ClinicalTrials.gov ID
- NCT00551395
- Acronym / sponsor ID
- RC-1
- Conditions
- Glaucoma
- Keywords
- glaucoma, laser, trabeculoplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 31 Oct 2007 (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.
This study will evaluate the effect of the timing of treatment completion in two-staged selective laser trabeculoplasty therapy on intraocular pressure lowering effect.
Detailed description
SLT therapy is used as an IOP lowering agent in patients with glaucoma. It is unknown whether the timing of a 2-staged approach to the laser therapy will result in better IOP lowering effect.
This study will evaluate the timing (early vs. late completion of SLT therapy) and determined the IOP lowering effect following the interventions.
Arm 1: Early Completion SLT
180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees on Day 2
Arm 2: Late Completion SLT
180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees at the 1 month follow up visit.
Primary Outcome: IOP (mmHg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLT Early Completion (Arm 1) | Experimental | Procedure: selective laser trabeculoplasty - early completionIntervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degree on Day 2 |
| SLT Late Completion (Arm 2) | Active comparator | Procedure: Selective laser trabeculoplasty - late completionIntervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degrees at 1 month follow up appointment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age
- primary open angle glaucoma or pseudoexfoliation glaucoma
Key exclusion criteria (1 listed)
- Unable to give informed consent
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 |
|---|---|---|
| selective laser trabeculoplasty - early completion180 degrees of laser on day 1 and other 180 degrees on day 2. | Procedure or surgery | SLT Early Completion (Arm 1) |
| Selective laser trabeculoplasty - late completion180 degrees of laser on day 1 and other 180 degrees at 1 month follow up point. | Procedure or surgery | SLT Late Completion (Arm 2) |
Primary outcome
intraocular pressure lowering
Time frame: 1 month following procedure
1 secondary outcome
intraocular pressure lowering
Time frame: 3, 6, 12 and 24 months following procedure
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
- 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.
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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.
Robert J Campbell, MD principal investigator
Queen's University, Kingston, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing selective laser trabeculoplasty - early completion and Selective laser trabeculoplasty - late completion in people with Glaucoma, run by Queen's University 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: stopped early, as of the sponsor's last update on 23 Sep 2015. 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.
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?
The study was stopped early (reason given: Poor recruitment). 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 lowering (time frame: 1 month following procedure). 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 NCT00551395, 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 23 Sep 2015; AzTrials last refreshed its copy on 7 Nov 2026.