GlaucomaSLOSNCT03164941
Effect of SLT Location on Treatment Outcomes
An observational study of Glaucoma, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
Selective Laser Trabeculoplasty (SLT) is a glaucoma treatment that has been shown to effectively lower intraocular pressure by increasing aqueous outflow through macrophage recruitment. There is evidence of increased drainage in the nasal quadrants of the eye. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Selective Laser Trabeculoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 84 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2017to 1 Dec 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients will be recruited from the glaucoma practice at St. Joseph's Healthcare Hamilton. A baseline clinical eye examination will be completed to include or exclude the participant from the study according to the criteria below. The baseline exam will include a comprehensive questionnaire of the participant's past ocular history, relevant systemic diseases, glaucoma risk factors, and surgical history.
Who may be able to join
- Diagnosis of open angle glaucoma, ocular hypertension, pigmentary dispersion syndrome and pseudoexfoliation syndrome
- Participant must be over 18 years of age
- IOP > 16mmHg on at least two consecutive occasions separated by one month
- Two sighted eyes with visual acuity of 20/200 or better
- Informed consent from patient
Who cannot join
- Diagnosis of secondary OAG (aside from pigmentary and pseudoexfoliation glaucoma) or narrow angle glaucoma
- Previous incisional glaucoma surgery
- Incisional glaucoma surgery scheduled within 1 year of intervention
- Corneal disease affecting visualization of anterior chamber of the eye
- Treatment or plan to treat with topical or systemic steroids
- Previous selective laser trabeculoplasty treatment
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St Joseph's Healthcare Hamilton - King Campus
Hamilton, Ontario
Sharan Bains, MD, 905-522-1155 ext. 38504, bainss@mcmaster.ca
About this study
Official title: Effect of 180 Degree Selective Laser Trabeculoplasty Location on Treatment Outcomes
Selective Laser Trabeculoplasty (SLT) is a glaucoma treatment that has been shown to effectively lower intraocular pressure by increasing aqueous outflow through macrophage recruitment. There is evidence of increased drainage in the nasal quadrants of the eye. This study aims to compare whether there is a difference in the reduction of eye pressure when SLT is performed nasally and temporally.
Read the detailed description
This study aims to evaluate if there is a difference between 180 degree nasal and temporal selective laser trabeculoplasty (SLT) in treatment outcomes. It is known that there is increased aqueous collectors and veins and thus aqueous drainage in the nasal quadrants of the eye. If SLT works by the hypothesized biologic mechanism in which macrophages remodel the aqueous drainage system to increase outflow, performing SLT in an area concentrated with aqueous veins may increase outflow more. As a result, we hypothesize that nasal 180 degree SLT may have better outcomes compared to the temporal counterpart. The results of this study may help inform decisions when performing 180 degree SLT and provide insight to SLT's mechanism of action. The primary objective of this study is to determine if there is a difference in treatment efficacy between nasal and temporal 180 degree SLT by measuring differences in baseline and post-operative intraocular pressures. We hypothesize that nasal SLT will have superior outcomes compared to temporal SLT due to increased number of aqueous veins.
- Conditions
- Glaucoma
- Being tested
- Selective Laser Trabeculoplasty
- Keywords
- selective laser trabeculoplasty, practice, treatment, 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.
Selective Laser TrabeculoplastyProcedure or surgery
Laser treatment for glaucoma.
| Study group | Role | What they receive |
|---|---|---|
| Nasal SLT | This cohort will have 180 degree SLT completed on the nasal quadrants of the trabecular meshwork. Receives: Procedure: Selective Laser Trabeculoplasty | |
| Temporal SLT | This cohort will have 180 degree SLT completed on the temporal quadrants of the trabecular meshwork. 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 primary outcome in this study is the change in intraocular pressure from baseline to the 1 year follow-up visit (continuous variable). The percentage decrease in IOP from baseline will also be calculated and compared between the two groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enitan Sogbesan, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164941
- Sponsor's protocol ID
- 0000000000
- Acronym
- SLOS
- Status last verified
- May 2017
- First submitted
- 22 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 180 Degree Selective Laser Trabeculoplasty Location on Treatment Outcomes
- ClinicalTrials.gov ID
- NCT03164941
- Acronym / sponsor ID
- SLOS / 0000000000
- Conditions
- Glaucoma
- Keywords
- selective laser trabeculoplasty, practice, treatment, intraocular pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 24 May 2017 (actual)
- 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.
Selective Laser Trabeculoplasty (SLT) is a glaucoma treatment that has been shown to effectively lower intraocular pressure by increasing aqueous outflow through macrophage recruitment. There is evidence of increased drainage in the nasal quadrants of the eye. This study aims to compare whether there is a difference in the reduction of eye pressure when SLT is performed nasally and temporally.
Detailed description
This study aims to evaluate if there is a difference between 180 degree nasal and temporal selective laser trabeculoplasty (SLT) in treatment outcomes. It is known that there is increased aqueous collectors and veins and thus aqueous drainage in the nasal quadrants of the eye. If SLT works by the hypothesized biologic mechanism in which macrophages remodel the aqueous drainage system to increase outflow, performing SLT in an area concentrated with aqueous veins may increase outflow more. As a result, we hypothesize that nasal 180 degree SLT may have better outcomes compared to the temporal counterpart. The results of this study may help inform decisions when performing 180 degree SLT and provide insight to SLT's mechanism of action. The primary objective of this study is to determine if there is a difference in treatment efficacy between nasal and temporal 180 degree SLT by measuring differences in baseline and post-operative intraocular pressures. We hypothesize that nasal SLT will have superior outcomes compared to temporal SLT due to increased number of aqueous veins.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal SLT | – | Procedure: Selective Laser TrabeculoplastyThis cohort will have 180 degree SLT completed on the nasal quadrants of the trabecular meshwork. |
| Temporal SLT | – | Procedure: Selective Laser TrabeculoplastyThis cohort will have 180 degree SLT completed on the temporal quadrants of the trabecular meshwork. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be recruited from the glaucoma practice at St. Joseph's Healthcare Hamilton. A baseline clinical eye examination will be completed to include or exclude the participant from the study according to the criteria below. The baseline exam will include a comprehensive questionnaire of the participant's past ocular history, relevant systemic diseases, glaucoma risk factors, and surgical history.
Key inclusion criteria (5 listed)
- Diagnosis of open angle glaucoma, ocular hypertension, pigmentary dispersion syndrome and pseudoexfoliation syndrome
- Participant must be over 18 years of age
- IOP > 16mmHg on at least two consecutive occasions separated by one month
- Two sighted eyes with visual acuity of 20/200 or better
- Informed consent from patient
Key exclusion criteria (6 listed)
- Diagnosis of secondary OAG (aside from pigmentary and pseudoexfoliation glaucoma) or narrow angle glaucoma
- Previous incisional glaucoma surgery
- Incisional glaucoma surgery scheduled within 1 year of intervention
- Corneal disease affecting visualization of anterior chamber of the eye
- Treatment or plan to treat with topical or systemic steroids
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 TrabeculoplastyLaser treatment for glaucoma. | Procedure or surgery | Nasal SLT, Temporal SLT |
Primary outcome
Intraocular Pressure
Time frame: 1 year
The primary outcome in this study is the change in intraocular pressure from baseline to the 1 year follow-up visit (continuous variable). The percentage decrease in IOP from baseline will also be calculated and compared between the two groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
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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.
St Joseph's Healthcare Hamilton - King Campus
Hamilton, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by St. Joseph's Healthcare Hamilton 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 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 24 May 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (time frame: 1 year). 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 24 May 2017.