Effect of SLT Location on Treatment Outcomes

• Conditions: Glaucoma
• Interventions: Procedure: Selective Laser Trabeculoplasty

• Registration Number: NCT03164941
• Lead Sponsor: St. Joseph's Healthcare Hamilton

Brief Summary

Selective Laser Trabeculoplasty (SLT) is a glaucoma treatment that has been shown to effectively lower intraocular pressure by increasing aqueous outflow through macrophage recruitment. There is evidence of increased drainage in the nasal quadrants of the eye. This study aims to compare whether there is a difference in the reduction of eye pressure when SLT is performed nasally and temporally.

Detailed Description

This study aims to evaluate if there is a difference between 180 degree nasal and temporal selective laser trabeculoplasty (SLT) in treatment outcomes. It is known that there is increased aqueous collectors and veins and thus aqueous drainage in the nasal quadrants of the eye. If SLT works by the hypothesized biologic mechanism in which macrophages remodel the aqueous drainage system to increase outflow, performing SLT in an area concentrated with aqueous veins may increase outflow more. As a result, we hypothesize that nasal 180 degree SLT may have better outcomes compared to the temporal counterpart. The results of this study may help inform decisions when performing 180 degree SLT and provide insight to SLT's mechanism of action. The primary objective of this study is to determine if there is a difference in treatment efficacy between nasal and temporal 180 degree SLT by measuring differences in baseline and post-operative intraocular pressures. We hypothesize that nasal SLT will have superior outcomes compared to temporal SLT due to increased number of aqueous veins.

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-22
• Last Update Submitted: 2017-05-22
• Study First Posted: 2017-05-24
• Last Update Posted: 2017-05-24
• Study Start: 2017-07-01
• Primary Completion: 2019-12-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Diagnosis of open angle glaucoma, ocular hypertension, pigmentary dispersion syndrome and pseudoexfoliation syndrome
• Participant must be over 18 years of age
• IOP > 16mmHg on at least two consecutive occasions separated by one month
• Two sighted eyes with visual acuity of 20/200 or better
• Informed consent from patient

Exclusion Criteria

• Diagnosis of secondary OAG (aside from pigmentary and pseudoexfoliation glaucoma) or narrow angle glaucoma
• Previous incisional glaucoma surgery
• Incisional glaucoma surgery scheduled within 1 year of intervention
• Corneal disease affecting visualization of anterior chamber of the eye
• Treatment or plan to treat with topical or systemic steroids
• Previous selective laser trabeculoplasty treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nasal SLT	Selective Laser Trabeculoplasty	This cohort will have 180 degree SLT completed on the nasal quadrants of the trabecular meshwork.
Temporal SLT	Selective Laser Trabeculoplasty	This cohort will have 180 degree SLT completed on the temporal quadrants of the trabecular meshwork.

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure	1 year	The primary outcome in this study is the change in intraocular pressure from baseline to the 1 year follow-up visit (continuous variable). The percentage decrease in IOP from baseline will also be calculated and compared between the two groups.

Trial Locations

Locations (1)

St Joseph's Healthcare Hamilton - King Campus; 🇨🇦 Hamilton, Ontario, Canada