180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma

Not Applicable

Completed

• Conditions: Glaucoma, Open Angle, Pseudo-exfoliative; Glaucoma; Open Angle Glaucoma; Ocular Hypertension; Pigment Dispersion Syndrome
• Interventions: Procedure: Selective Laser Trabeculoplasty

• Registration Number: NCT02628223
• Lead Sponsor: Temple University

Brief Summary

Selective laser trabeculoplasty (SLT) is a well-recognized way to lower eye pressure in treatment of glaucoma. This treatment is performed for 180 degrees or 360 degrees, and studies at academic centers have shown mixed results when comparing the success rates of 180 degrees or 360 degrees. Both protocols are now typically done by comprehensive ophthalmologists. However, there is no data that compares success rates of 180 degrees and 360 degrees in the community setting.

Detailed Description

This study is designed as a prospective evaluation of the two treatment algorithms for SLT by measuring intraocular pressure (IOP) after treatment. The hypothesis is that 360 degrees of SLT will produce a greater reduction in IOP than 180 degrees of SLT at 3 months follow up.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-11
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Results First Submitted: 2020-10-12
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-03
• Last Update Submitted: 2020-11-03
• Results First Posted: 2020-11-05
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• patients who have been diagnosed with open-angle glaucoma including ocular hypertension, pseudoexfoliation and pigment dispersion syndrome
• greater than 18 years of age
• initial intraocular pressure (IOP) of ≥ 21 mmHg

Exclusion Criteria

• prior medical or laser therapy to lower IOP
• previous incisional glaucoma surgery before the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
180 degrees	Selective Laser Trabeculoplasty	180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser
360 degrees	Selective Laser Trabeculoplasty	360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up	3 months	Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at three months of follow-up

Secondary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at 1 Year of Follow-up	1 year	Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at 1 year of follow-up
Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Time at Which Additional Glaucoma Therapy is Required	within 1 year of study intervention	Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at time at which additional glaucoma therapy is required
Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Last Follow-up	within 1 year of study intervention	Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at last follow-up

Trial Locations

Locations (2)

Brandywine Eye Center; 🇺🇸 Wilmington, Delaware, United States

Levin Luminais Chronister Eye Associates; 🇺🇸 Thorndale, Pennsylvania, United States