Effect of SLT Location on Treatment Outcomes

NCT ID: NCT03164941

Last Updated: 2017-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-12-01

Brief Summary

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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

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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.

Conditions

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Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Nasal SLT

This cohort will have 180 degree SLT completed on the nasal quadrants of the trabecular meshwork.

Selective Laser Trabeculoplasty

Intervention Type PROCEDURE

Laser treatment for glaucoma.

Temporal SLT

This cohort will have 180 degree SLT completed on the temporal quadrants of the trabecular meshwork.

Selective Laser Trabeculoplasty

Intervention Type PROCEDURE

Laser treatment for glaucoma.

Interventions

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Selective Laser Trabeculoplasty

Laser treatment for glaucoma.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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Enitan Sogbesan

Ophthalmologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St Joseph's Healthcare Hamilton - King Campus

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Sharan Bains, MD

Role: primary

905-522-1155 ext. 38504

Other Identifiers

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0000000000

Identifier Type: -

Identifier Source: org_study_id

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