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

NCT03529591 | Completed

• 1 other identifier: 111317
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The number of participants with treatment-related adverse events will be assessed by CTCAE v4.0.

  Six months

Study Arms (2)

180 deg selective laser trabeculoplasty

ACTIVE COMPARATOR

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

360 deg selective laser trabeculoplasty

ACTIVE COMPARATOR

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

Interventions

Selective laser trabeculoplasty (SLT) DEVICE

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

180 deg selective laser trabeculoplasty; 360 deg selective laser trabeculoplasty

Selective laser trabeculoplasty PROCEDURE

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.

180 deg selective laser trabeculoplasty; 360 deg selective laser trabeculoplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

Location

Related Publications (1)

• 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.

  PMID: 35943114 DERIVED

MeSH Terms

Conditions

Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Tony Lin, MD

  Ivey Eye Institute, St Joseph's Healthcare, Western University, London, Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Ophthalmology, Western University

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 18, 2018
• Study Start: June 29, 2018
• Primary Completion: January 27, 2021
• Study Completion: May 3, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)