Clarifying the Optimal Application of SLT Therapy Trial (COAST)
Glaucoma and Ocular Hypertension
About this trial
This is an interventional treatment trial for Glaucoma and Ocular Hypertension focused on measuring glaucoma, selective laser trabeculoplasty, clinical trial
Eligibility Criteria
Inclusion Criteria:
1. In good health, newly diagnosed and treatment naïve (no prior IOP-lowering treatments), with decision to treat made by an ophthalmologist on the basis of risk profile, patient preference, or both 3. Age 18 years or older 4. Each eye with BCVA at least 20/200 (UK 6/60) 5. Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes):
- High-risk ocular hypertension (OHT): IOP > 21 mmHg without glaucomatous optic neuropathy (excavation, diffuse or focal thinning or notching of the neuroretinal rim, visible nerve fiber layer defects, or asymmetry of the vertical cup-to-disc ratio of >0.2 between eyes) [enrollment of trial participants with High-risk OHT will be capped at 25% of total enrollment]
- Mild primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation >-6.0 dB with no points in the central 5° <15 dB
- Moderate primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation -6.0 dB to >-12 dB and no more than 1 central 5° point <15 dB
Exclusion Criteria:
- Advanced POAG in either eye
- Glaucoma other than POAG (including pigmentary and pseudoexfoliation glaucoma) in either eye
- Mean IOP > 35 mmHg at either the screening or baseline visit in either eye
- Narrow or closed angle (Shaffer Grade 0, 1, or 2) in either eye
- Contraindications to SLT, brimonidine, or any other study intervention
- Any corneal pathology that would preclude accurate assessment of IOP by Goldmann tonometry in either eye
- Any intraocular surgical procedure within the past 6 months in either eye
- Inability to attend all scheduled study visits
Sites / Locations
- Harvard Eye AssociatesRecruiting
- Doheny Eye Center UCLARecruiting
- University of California, DavisRecruiting
- University of California, San FranciscoRecruiting
- Mile High Eye InstituteRecruiting
- Clear Vue Laser Eye CenterRecruiting
- Northwestern Medical GroupRecruiting
- Arbors Centers for Eye CareRecruiting
- Illinois Eye CenterRecruiting
- Wilmer Eye Institute Johns HopkinsRecruiting
- Massachusetts Eye and EarRecruiting
- Ophthalmic Consultants of BostonRecruiting
- Mark Latina, LLCRecruiting
- University of Michigan Kellogg Eye Center
- Kresge Eye Institute Wayne State UniversityRecruiting
- New York Eye Surgery AssociatesRecruiting
- University Hospitals Eye InstituteRecruiting
- Cleveland Clinic Cole Eye InstituteRecruiting
- Devers Eye InstituteRecruiting
- Eye Care Specialists
- Scheie Eye InstituteRecruiting
- Wills Eye HospitalRecruiting
- UPMC Eye CenterRecruiting
- Vanderbilt Eye InstituteRecruiting
- Ophthalmology AssociatesRecruiting
- Spokane Eye Clinical ResearchRecruiting
- West Virginia UniversityRecruiting
- University of Wisconsin-MadisonRecruiting
- Ocular Health Centre
- Moorfields Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Active Comparator
First Randomization: Low Energy SLT
First Randomization: Standard Energy SLT
Second Randomization: Annual Low Energy Repeat SLT
Second Randomization: As-Needed Repeat SLT at Initial Energy
Low energy SLT will consist of 100 treatment spots delivered at 0.4mJ per spot throughout the full 360° treatment, with the exception that energy can be reduced to 0.3mJ if bubbles are seen with 5 consecutive spots and can be increased back to a maximum of 0.4mJ is no bubbles are seen with 5 consecutive spots. Regardless of energy level randomization, energy may be adjusted downward in 0.1mJ increments throughout the procedure in response to factors such as heavy focal pigmentation or patient discomfort.
Standard SLT will be performed as follows: beginning at 0.8 mJ, energy will be titrated up or down within the first 5-10 spots until champagne bubbles are visualized with every 2nd or 3rd spot. Energy can be titrated throughout the procedure, in response to variations in pigmentation, to ensure the appearance of champagne bubbles with every 2nd or 3rd spot throughout the full 360° treatment. Energy should be increased if no bubbles are seen with 5 consecutive spots and decreased if bubbles are seen with 5 consecutive spots. Regardless of energy level randomization, energy may be adjusted downward in 0.1mJ increments throughout the procedure in response to factors such as heavy focal pigmentation or patient discomfort.
At month 12, subjects remaining medication-free will be re-randomized to undergo repeat SLT either annually at low energy or as needed at initially assigned energy (from first randomization). The method of SLT delivery is as described in the sections above.
At month 12, subjects remaining medication-free will be re-randomized to undergo repeat SLT either annually at low energy or as needed at initially assigned energy (from first randomization). The method of SLT delivery is as described in the sections above.