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

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension, Glaucoma, Open Angle, Pseudo-exfoliative

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Selective Laser Trabeculoplasty

Neodymium:Yttrium Aluminum Garnet (YAG) laser

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring glaucoma, Elevated IOP, Selective Laser Trabeculoplasty, SLT, open angle glaucoma, ocular hypertension, Glaucoma, Open Angle, Pseudo-exfoliative, pigment dispersion syndrome, Pseudoexfoliation, IOP ≥ 21 mmHg

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Brandywine Eye Center
Levin Luminais Chronister Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

180 degrees

360 degrees

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT02628223

First Posted

November 23, 2015

Last Updated

November 3, 2020

Sponsor

Temple University

1. Study Identification

Unique Protocol Identification Number

NCT02628223

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Temple University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

glaucoma, Elevated IOP, Selective Laser Trabeculoplasty, SLT, open angle glaucoma, ocular hypertension, Glaucoma, Open Angle, Pseudo-exfoliative, pigment dispersion syndrome, Pseudoexfoliation, IOP ≥ 21 mmHg

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

180 degrees

Arm Type

Active Comparator

Arm Description

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

Arm Title

360 degrees

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Selective Laser Trabeculoplasty

Other Intervention Name(s)

SLT

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Neodymium:Yttrium Aluminum Garnet (YAG) laser

Other Intervention Name(s)

Nd:YAG laser

Intervention Description

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.

Primary Outcome Measure Information:

Title

Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up

Description

Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at three months of follow-up

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at 1 Year of Follow-up

Description

Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at 1 year of follow-up

Time Frame

1 year

Title

Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Time at Which Additional Glaucoma Therapy is Required

Description

Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at time at which additional glaucoma therapy is required

Time Frame

within 1 year of study intervention

Title

Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Last Follow-up

Description

Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at last follow-up

Time Frame

within 1 year of study intervention

Other Pre-specified Outcome Measures:

Title

Number of Participants With Intraocular Pressure (IOP) Spike Assessed by Tonometry

Description

If IOP spike occurs, it will be treated accordingly.

Time Frame

within 1 year of study intervention

Title

Number of Participants With Trabeculitis Assessed by Ophthalmic Exam and Gonioscopy

Description

If trabeculitis occurs, it will be treated accordingly.

Time Frame

within 1 year of study intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey D. Henderer, MD

Organizational Affiliation

Temple University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sophia Siu, MD

Organizational Affiliation

Temple University

Official's Role

Study Director

Facility Information:

Facility Name

Brandywine Eye Center

City

Wilmington

State/Province

Delaware

ZIP/Postal Code

19810

Country

United States

Facility Name

Levin Luminais Chronister Eye Associates

City

Thorndale

State/Province

Pennsylvania

ZIP/Postal Code

19372

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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