Ocular Hypertension Clinical Trial
— SLTOfficial title:
Is the Reduction in Intraocular Pressure Achieved With Treatment of 180 Degrees Equivalent to Treatment of 360 Degrees With Selective Laser Trabeculoplasty (SLT)?
NCT number | NCT03529591 |
Other study ID # | 111317 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 29, 2018 |
Est. completion date | May 3, 2021 |
Verified date | May 2022 |
Source | Western University, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 3, 2021 |
Est. primary completion date | January 27, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | St. Joseph's Health Care London | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Western University, Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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? | Six months | |
Secondary | 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. | Six months |
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