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

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ClinicalTrials.gov Identifier: NCT03529591
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Tony Lin, Western University, Canada

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.


Condition or disease Intervention/treatment Phase
Ocular Hypertension Primary Open Angle Glaucoma of Both Eyes Intraocular Pressure Device: Selective laser trabeculoplasty (SLT) Procedure: Selective laser trabeculoplasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)?
Actual Study Start Date : June 29, 2018
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. 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?


Secondary Outcome Measures :
  1. The number of participants with treatment-related adverse events will be assessed by CTCAE v4.0. [ Time Frame: Six months ]
    The adverse events/complications in eyes treated with 180 degrees SLT compared to 360 degrees SLT will be assessed and analysed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529591


Contacts
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Contact: Tony Lin, MD 5196466225 Tony.Lin@sjhc.london.on.ca
Contact: Aparna Raniga, MBChB 5196466226 Aparna.Raniga@lhsc.on.ca

Locations
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Canada, Ontario
St. Joseph's Health Care London Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Tony Lin, MD         
Sponsors and Collaborators
Western University, Canada
Investigators
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Principal Investigator: Tony Lin, MD Ivey Eye Institute, St Joseph's Healthcare, Western University, London, Ontario, Canada
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Responsible Party: Tony Lin, Assistant Professor Ophthalmology, Western University, Western University, Canada
ClinicalTrials.gov Identifier: NCT03529591    
Other Study ID Numbers: 111317
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Glaucoma
Eye Diseases