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

Glaucoma Clinical Trial

Official title:

A Randomized Trial of 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02628223
• Other study ID #: 21921
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2017

Study information

• Verified date: November 2020
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open Angle, Pseudo-exfoliative
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma
• Pigment Dispersion Syndrome

Intervention

Procedure:
• Selective Laser Trabeculoplasty
The procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.

Device:
• Neodymium:Yttrium Aluminum Garnet (YAG) laser
The procedure uses a 400 µm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.

Locations

Country	Name	City	State
United States	Levin Luminais Chronister Eye Associates	Thorndale	Pennsylvania
United States	Brandywine Eye Center	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Intraocular Pressure (IOP) Spike Assessed by Tonometry	If IOP spike occurs, it will be treated accordingly.	within 1 year of study intervention
Other	Number of Participants With Trabeculitis Assessed by Ophthalmic Exam and Gonioscopy	If trabeculitis occurs, it will be treated accordingly.	within 1 year of study intervention
Primary	Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up	Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at three months of follow-up	3 months
Secondary	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 1 year of follow-up	1 year
Secondary	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 time at which additional glaucoma therapy is required	within 1 year of study intervention
Secondary	Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Last Follow-up	Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at last follow-up	within 1 year of study intervention