Open Angle Glaucoma
Conditions
Brief summary
The purpose of this study to optimize Selective Laser Trabeculoplasty (SLT) application when used in the management of open angle glaucoma (OAG)
Detailed description
The purpose of this research is to determine the most effective method in using Selective Laser Trabeculoplasty (SLT) for lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. We will investigate the IOP lowering differences between nasal 180° SLT and inferior 180° SLT,. The second stage will assess the effect of repeating SLT in the opposite 180° sector after 3 months.
Interventions
PROCEDURENasal 180° Selective Laser Trabeculoplasty (SLT)
The Nasal 180° Selective Laser Trabeculoplasty (SLT) will be performed on the right eye. As per standard procedure, the laser will initially be set at 0.8 mJ (or 0.4 mJ for heavily pigmented TM). The energy level will then be adjusted in 0.1 mJ increments: increased until micro-bubble formation is observed or decreased if bubbles are noted. The desired endpoint is the production of a few fine 'champagne bubbles' every 2-3 laser spots. Larger gas bubbles and trabecular meshwork blanching will require the operator to titrate the power downwards in 0.1 mJ increments. Prophylactic IOP lowering and anti-inflammatory drops will be left to physician preference.
PROCEDUREInferior 180° Selective Laser Trabeculoplasty (SLT)
The Inferior 180° Selective Laser Trabeculoplasty (SLT) will be performed on the right eye. As per standard procedure, the laser will initially be set at 0.8 mJ (or 0.4 mJ for heavily pigmented TM). The energy level will then be adjusted in 0.1 mJ increments: increased until micro-bubble formation is observed or decreased if bubbles are noted. The desired endpoint is the production of a few fine 'champagne bubbles' every 2-3 laser spots. Larger gas bubbles and trabecular meshwork blanching will require the operator to titrate the power downwards in 0.1 mJ increments. Prophylactic IOP lowering and anti-inflammatory drops will be left to physician preference.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and older * Ability to comprehend the study procedures and agreement to proceed with primary SLT treatment * Diagnosis of primary or secondary open angle glaucoma or glaucoma suspects with ocular hypertension * Bilateral disease * Pre-SLT IOP \>21 mmHg measured at least twice during patient's lifetime with or without medication * Open angles with moderate to intense trabecular pigmentation * Mild to moderate visual field defects (24-2 standard mean deviations better than the Swedish interactive thresholding algorithm standard of 12 dB) * No adequate IOP control (low treatment compliance, substantial adverse effects with eyedrops, and at least 2 IOP measurements higher than the individualized target IOP)
Exclusion criteria
* Unwilling or unable to give consent * Unable to attend scheduled post-operative visits * Previous history of either laser treatment or intraocular surgery, except for non-complicated cataract surgery (performed \>6 months before SLT) * History of ocular trauma * Narrow angles * Retinal detachment * Active iris neovascularization or active proliferative retinopathy * Active uveitis * Monocular patients * Current use of steroids (ocular, periocular, or systemic)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in mean intraocular pressure (IOP) | Baseline, 3 months, 6 months, 9 months | During each visit, two consecutive IOP measurements will be obtained per eye, and the average of these values will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in intraocular pressure (IOP) | Baseline, 3 months, 6 months, 9 months | Change in intraocular pressure (IOP), reported as a percentage |
| Intraocular pressure (IOP) lowering eye drops | 9 months | Total number of patients that did not need intraocular pressure (IOP) lowering drops after the selective laser trabeculoplasty (SLT) |
Countries
Canada, United States
Outcome results
None listed