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

Primary Purpose

Ocular Hypertension, Primary Open Angle Glaucoma of Both Eyes, Intraocular Pressure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Selective laser trabeculoplasty (SLT)
Selective laser trabeculoplasty
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Health Care London

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

180 deg selective laser trabeculoplasty

360 deg selective laser trabeculoplasty

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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?

Secondary Outcome Measures

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.

Full Information

First Posted
May 3, 2018
Last Updated
May 3, 2022
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03529591
Brief Title
Is the Reduction in IOP After Treatment of 180 Degrees Equivalent to Treatment of 360 Degrees With SLT?
Acronym
SLT
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)?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 29, 2018 (Actual)
Primary Completion Date
January 27, 2021 (Actual)
Study Completion Date
May 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 . 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Primary Open Angle Glaucoma of Both Eyes, Intraocular Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
180 deg selective laser trabeculoplasty
Arm Type
Active Comparator
Arm Description
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.
Arm Title
360 deg selective laser trabeculoplasty
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Selective laser trabeculoplasty (SLT)
Other Intervention Name(s)
Selective laser trabeculoplasty
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Selective laser trabeculoplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraocular pressure response (physiological parameter)
Description
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
Secondary Outcome Measure Information:
Title
The number of participants with treatment-related adverse events will be assessed by CTCAE v4.0.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Lin, MD
Organizational Affiliation
Ivey Eye Institute, St Joseph's Healthcare, Western University, London, Ontario, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35943114
Citation
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.
Results Reference
derived

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

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