Ocular HypertensionSLTNCT03529591
Is the Reduction in IOP After Treatment of 180 Degrees Equivalent to Treatment of 360 Degrees With SLT?
A study testing Selective laser trabeculoplasty (SLT) and Selective laser trabeculoplasty in people with Ocular Hypertension and Primary Open Angle Glaucoma of Both Eyes, run by Western University, Canada at 1 site in Canada.
Trial summary
The study is a prospective randomised controlled intervention comparing the intraocular pressure outcomes following Selective Laser Trabeculoplasty (SLT) treatment of 180 degrees SLT compared to 360 degrees in treatment naive patients with bilateral ocular hypertension or primary open angle glaucoma . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Primary Open Angle Glaucoma of Both Eyes, Intraocular Pressure
- What is being tested?
- Selective laser trabeculoplasty (SLT) and Selective laser trabeculoplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jun 2018to 3 May 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- IOP greater than 21mmHg (millimetres mercury)
- Glaucoma suspect
- Open angle glaucoma - primary or secondary
- Bilateral disease
- History of previous uncomplicated cataract surgery
- Willingness to be treated with selective laser trabeculoplasty
- Willingness to participate in the study, along with signed written consent
Who cannot join
- Age younger than 18 years
- Paediatric glaucoma
- Narrow or closed angles on gonioscopy
- History of ocular trauma
- Active or history of uveitis
- History of amblyopia
Show all 13Show fewer
- History of, or, current steroid use - ocular, periocular or systemic
- History of any prior ocular laser - Argon laser trabeculoplasty (ALT), SLT or retinal laser
- Monocular patient
- Active proliferative diabetic retinopathy
- History of complicated cataract surgery
- Recent cataract surgery - within the last six months
- Unable to consent for treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Reduction in Intraocular Pressure Achieved With Treatment of 180 Degrees Equivalent to Treatment of 360 Degrees With Selective Laser Trabeculoplasty (SLT)?
The study is a prospective randomised controlled intervention comparing the intraocular pressure outcomes following Selective Laser Trabeculoplasty (SLT) treatment of 180 degrees SLT compared to 360 degrees in treatment naive patients with bilateral ocular hypertension or primary open angle glaucoma . The right eye of each patient will be randomised to receive either 180 or 360 degrees SLT, while the fellow eye will receive the opposite treatment. That is, if the right eye is randomised to 180 degrees SLT, then the left eye will receive 360 degrees SLT.
The primary objective is to assess the mean difference in intraocular pressure between two eyes of each participant. The mean difference in IOP will be assessed at two weeks and at one, three and six months after treatment with SLT.
Secondary outcomes include assessing whether there are differences in visual acuity, anterior chamber inflammation, visual field progression and the rate of complications between the two eyes treated with either 180° or 360° of selective laser trabeculoplasty. The complications assessed are those published in the literature including: pain, blurred vision, anterior chamber inflammation, IOP spike, and hyphaema. Additionally, participants will be given the opportunity to report symptoms experienced through free text.
Read the detailed description
Potential patients will be identified by the Principal Investigator during a clinic visit. Pre-screening criteria is carried out by the co-investigator or the research co-ordinator. General eligibility criteria, inclusion and exclusion criteria are applied. The Research Co-ordinator approaches the patient and the SLT laser study is discussed with the patient. The patient is provided the Information Sheet and advised to contact the Research Coordinator if they wish to proceed. Informed consent is obtained if the patient wishes to proceed. Baseline data is collected and the right eye is randomised with the fellow eye to receive non randomised treatment.
SLT is performed in both eyes (180 degrees in 1 eye + 360 degrees in the fellow eye) during an office visit. IOP in both eyes is checked and recorded at one hour post treatment.
The patient returns for follow up at two weeks post SLT treatment visit. A complete ocular examination, including IOP, is undertaken. Complications and adverse events are assessed and recorded. Any change to eyedrops is recorded. Patients return at one, three and six months for review, and the same assessment as above is undertaken at each visit.
Enrolling is complete when 48 patients are enrolled. Patients are advised enrolling is complete.
Statistical analysis is undertaken to assess the mean change in IOP between the two treatments. Complications and adverse events are each treatment group are recorded. The study is submitted for publication and written communication is provided to each enrolled patient.
- Being tested
- Selective laser trabeculoplasty (SLT), Selective laser trabeculoplasty
- Medical subject headings
- Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective laser trabeculoplasty (SLT)Device
Also called Selective laser trabeculoplasty
In this study, treatment naive patients with bilateral ocular hypertension or primary open angle glaucoma are treated with 180 degrees SLT in one eye and 360 degrees SLT in the contralateral eye. The primary outcome measure is assessing the response to SLT in both eyes and comparing the intraocular pressure outcomes between the two eyes of each patient.
Selective laser trabeculoplastyProcedure or surgery
In this study, treatment naive patients with bilateral ocular hypertension or primary open angle glaucoma are treated with 180 degrees SLT in one eye and 360 degrees SLT in the contralateral eye. The primary outcome measure is assessing the response to SLT in both eyes and comparing the intraocular pressure outcomes between the two eyes of each patient.
| Study group | Role | What they receive |
|---|---|---|
| 180 deg selective laser trabeculoplasty | Active comparator | The right eye of a patient is randomized to be treated with either 180 or 360 degrees selective laser trabeculoplasty (SLT). The fellow eye is treated with the opposite treatment, that is, if the right eye is treated with 180 degrees SLT, the left eye is treated with 360 degrees SLT. Intraocular pressure (IOP) response is assessed at 2 weeks, one, three and six months post treatment and compared to the alternative treatment arm, the fellow eye. Receives: Device: Selective laser trabeculoplasty (SLT); Procedure: Selective laser trabeculoplasty |
| 360 deg selective laser trabeculoplasty | Active comparator | The right eye of a patient is randomized to be treated with either 180 or 360 degrees selective laser trabeculoplasty (SLT). The fellow eye is treated with the opposite treatment, that is, if the right eye is treated with 180 degrees SLT, the left eye is treated with 360 degrees SLT. Intraocular pressure (IOP) response is assessed at 2 weeks, one, three and six months post treatment and compared to the alternative treatment arm, the fellow eye. Receives: Device: Selective laser trabeculoplasty (SLT); Procedure: Selective laser trabeculoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure response (physiological parameter)
Is there a difference in the intraocular pressure response following SLT treatment of 180 degrees compared to SLT treatment of 360 degrees, in two eyes of the same patient treatment?
Measured: Six months
Secondary outcomes (1)
The number of participants with treatment-related adverse events will be assessed by CTCAE v4.0.
The adverse events/complications in eyes treated with 180 degrees SLT compared to 360 degrees SLT will be assessed and analysed.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start29 Jun 2018
- Primary completion27 Jan 2021
- Study completion3 May 2021
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 Ocular HypertensionStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tony Lin, Western University, Canada
- Investigators
- Tony Lin, MD, Principal investigator, Ivey Eye Institute, St Joseph's Healthcare, Western University, London, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529591
- Sponsor's protocol ID
- 111317
- Acronym
- SLT
- Status last verified
- May 2022
- First submitted
- 3 May 2018
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Reduction in Intraocular Pressure Achieved With Treatment of 180 Degrees Equivalent to Treatment of 360 Degrees With Selective Laser Trabeculoplasty (SLT)?
- ClinicalTrials.gov ID
- NCT03529591
- Acronym / sponsor ID
- SLT / 111317
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 18 May 2018 (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.
The study is a prospective randomised controlled intervention comparing the intraocular pressure outcomes following Selective Laser Trabeculoplasty (SLT) treatment of 180 degrees SLT compared to 360 degrees in treatment naive patients with bilateral ocular hypertension or primary open angle glaucoma . The right eye of each patient will be randomised to receive either 180 or 360 degrees SLT, while the fellow eye will receive the opposite treatment. That is, if the right eye is randomised to 180 degrees SLT, then the left eye will receive 360 degrees SLT.
The primary objective is to assess the mean difference in intraocular pressure between two eyes of each participant. The mean difference in IOP will be assessed at two weeks and at one, three and six months after treatment with SLT.
Secondary outcomes include assessing whether there are differences in visual acuity, anterior chamber inflammation, visual field progression and the rate of complications between the two eyes treated with either 180° or 360° of selective laser trabeculoplasty. The complications assessed are those published in the literature including: pain, blurred vision, anterior chamber inflammation, IOP spike, and hyphaema. Additionally, participants will be given the opportunity to report symptoms experienced through free text.
Detailed description
Potential patients will be identified by the Principal Investigator during a clinic visit. Pre-screening criteria is carried out by the co-investigator or the research co-ordinator. General eligibility criteria, inclusion and exclusion criteria are applied. The Research Co-ordinator approaches the patient and the SLT laser study is discussed with the patient. The patient is provided the Information Sheet and advised to contact the Research Coordinator if they wish to proceed. Informed consent is obtained if the patient wishes to proceed. Baseline data is collected and the right eye is randomised with the fellow eye to receive non randomised treatment.
SLT is performed in both eyes (180 degrees in 1 eye + 360 degrees in the fellow eye) during an office visit. IOP in both eyes is checked and recorded at one hour post treatment.
The patient returns for follow up at two weeks post SLT treatment visit. A complete ocular examination, including IOP, is undertaken. Complications and adverse events are assessed and recorded. Any change to eyedrops is recorded. Patients return at one, three and six months for review, and the same assessment as above is undertaken at each visit.
Enrolling is complete when 48 patients are enrolled. Patients are advised enrolling is complete.
Statistical analysis is undertaken to assess the mean change in IOP between the two treatments. Complications and adverse events are each treatment group are recorded. The study is submitted for publication and written communication is provided to each enrolled patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 180 deg selective laser trabeculoplasty | Active comparator | Device: Selective laser trabeculoplasty (SLT), Procedure: Selective laser trabeculoplastyThe right eye of a patient is randomized to be treated with either 180 or 360 degrees selective laser trabeculoplasty (SLT). The fellow eye is treated with the opposite treatment, that is, if the right eye is treated with 180 degrees SLT, the left eye is treated with 360 degrees SLT. Intraocular pressure (IOP) response is assessed at 2 weeks, one, three and six months post treatment and compared to the alternative treatment arm, the fellow eye. |
| 360 deg selective laser trabeculoplasty | Active comparator | Device: Selective laser trabeculoplasty (SLT), Procedure: Selective laser trabeculoplastyThe right eye of a patient is randomized to be treated with either 180 or 360 degrees selective laser trabeculoplasty (SLT). The fellow eye is treated with the opposite treatment, that is, if the right eye is treated with 180 degrees SLT, the left eye is treated with 360 degrees SLT. Intraocular pressure (IOP) response is assessed at 2 weeks, one, three and six months post treatment and compared to the alternative treatment arm, the fellow eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age greater than 18 years
- IOP greater than 21mmHg (millimetres mercury)
- Glaucoma suspect
- Open angle glaucoma - primary or secondary
- Bilateral disease
Key exclusion criteria (13 listed)
- Age younger than 18 years
- Paediatric glaucoma
- Narrow or closed angles on gonioscopy
- History of ocular trauma
- Active or history of uveitis
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 (SLT)Also: Selective laser trabeculoplastyIn this study, treatment naive patients with bilateral ocular hypertension or primary open angle glaucoma are treated with 180 degrees SLT in one eye and 360 degrees SLT in the contralateral eye. The primary outcome measure is assessing the response to SLT in both eyes and comparing the intraocular pressure outcomes between the two eyes of each patient. | Device | 180 deg selective laser trabeculoplasty, 360 deg selective laser trabeculoplasty |
| Selective laser trabeculoplastyIn this study, treatment naive patients with bilateral ocular hypertension or primary open angle glaucoma are treated with 180 degrees SLT in one eye and 360 degrees SLT in the contralateral eye. The primary outcome measure is assessing the response to SLT in both eyes and comparing the intraocular pressure outcomes between the two eyes of each patient. | Procedure or surgery | 180 deg selective laser trabeculoplasty, 360 deg selective laser trabeculoplasty |
Primary outcome
Intraocular pressure response (physiological parameter)
Time frame: Six months
Is there a difference in the intraocular pressure response following SLT treatment of 180 degrees compared to SLT treatment of 360 degrees, in two eyes of the same patient treatment?
1 secondary outcome
The number of participants with treatment-related adverse events will be assessed by CTCAE v4.0.
Time frame: Six 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 4 May 2022.
- 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.
- Individual participant dataSharing planned: No
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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.
Tony Lin, MD principal investigator
Ivey Eye Institute, St Joseph's Healthcare, Western University, London, Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective laser trabeculoplasty (SLT) and Selective laser trabeculoplasty in people with Ocular Hypertension and Primary Open Angle Glaucoma of Both Eyes, run by Western University, Canada 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 8 inclusion and 13 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 4 May 2022. 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 response (physiological parameter) (time frame: Six months). 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 NCT03529591, 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 4 May 2022.