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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Selective Laser Trabeculoplasty
* Device: Neodymium:Yttrium Aluminum Garnet (YAG) laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 180 degrees<br>180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser | Procedure: Selective Laser Trabeculoplasty<br>* 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.<br>* Other names: SLT;Device: Neodymium:Yttrium Aluminum Garnet (YAG) laser<br>* 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.<br>* Other names: Nd:YAG laser;|
| Active Comparator: 360 degrees<br>360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser | Procedure: Selective Laser Trabeculoplasty<br>* 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.<br>* Other names: SLT;Device: Neodymium:Yttrium Aluminum Garnet (YAG) laser<br>* 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.<br>* Other names: Nd:YAG laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, Elevated IOP, Selective Laser Trabeculoplasty, SLT, open angle glaucoma, ocular hypertension, Glaucoma, Open Angle, Pseudo-exfoliative, pigment dispersion syndrome, Pseudoexfoliation, IOP ≥ 21 mmHg