NCT03164941

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

2.4 years

First QC Date

May 22, 2017

Last Update Submit

May 22, 2017

Conditions

Keywords

selective laser trabeculoplastypracticetreatmentintraocular pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Nasal SLT

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

Procedure: Selective Laser Trabeculoplasty

Temporal SLT

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

Procedure: Selective Laser Trabeculoplasty

Interventions

Laser treatment for glaucoma.

Nasal SLTTemporal SLT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients will be recruited from the glaucoma practice at St. Joseph's Healthcare Hamilton. A baseline clinical eye examination will be completed to include or exclude the participant from the study according to the criteria below. The baseline exam will include a comprehensive questionnaire of the participant's past ocular history, relevant systemic diseases, glaucoma risk factors, and surgical history.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Joseph's Healthcare Hamilton - King Campus

Hamilton, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmologist

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 24, 2017

Study Start

July 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

May 24, 2017

Record last verified: 2017-05

Locations