Effect of SLT Location on Treatment Outcomes

Glaucoma Clinical Trial

— SLOS  

Official title:

Effect of 180 Degree Selective Laser Trabeculoplasty Location on Treatment Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03164941
• Other study ID #: 0000000000
• Status: Recruiting
• Phase: N/A
• First received: May 22, 2017
• Last updated: May 22, 2017
• Start date: July 1, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: May 2017
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• Selective Laser Trabeculoplasty
Laser treatment for glaucoma.

Locations

Country	Name	City	State
Canada	St Joseph's Healthcare Hamilton - King Campus	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure	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.	1 year