An interventional study of Selective laser trabeculoplasty (SLT) and Selective laser trabeculoplasty in Ocular Hypertension, Primary Open Angle Glaucoma of Both Eyes and Intraocular Pressure, sponsored by Western University, Canada. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-04.
Sponsored by Western University, Canada · Not applicable, Interventional, and Treatment
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.
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.
929 studies on the registry are indexed under Glaucoma, Open-Angle; 122 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 700 interventional studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →Western University, Canada is the lead sponsor of 221 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Selective laser trabeculoplasty (SLT) · Procedure: Selective laser trabeculoplasty
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.
Device: Selective laser trabeculoplasty (SLT) · Procedure: 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.
Also known as: 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.
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?
Time frame: Six months
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.
Time frame: Six months
Plan to share: No
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Western University, Canada