Is the Reduction in IOP After Treatment of 180 Degrees Equivalent to Treatment of 360 Degrees With SLT? (SLT)

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Intraocular Pressure; Primary Open Angle Glaucoma of Both Eyes
• Intervention / Treatment: Device: Selective laser trabeculoplasty (SLT); Procedure: Selective laser trabeculoplasty

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St. Joseph's Health Care London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 180 deg 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); 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.; Other Names: Selective laser trabeculoplasty; 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.
Active Comparator: 360 deg 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); 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.; Other Names: Selective laser trabeculoplasty; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Western University, Canada
• Investigators: Principal Investigator: Tony Lin, MD, Ivey Eye Institute, St Joseph's Healthcare, Western University, London, Ontario, Canada

Publications and helpful links

General 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:CD003919. doi: 10.1002/14651858.CD003919.pub3. Review.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2018
• Primary Completion (Actual): January 27, 2021
• Study Completion (Actual): May 3, 2021

Study Registration Dates

• First Submitted: May 3, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension
• Other Study ID Numbers: 111317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No