Clarifying the Optimal Application of SLT Therapy Trial
NCT ID: NCT04967989
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
790 participants
INTERVENTIONAL
2021-09-07
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Initial Design: Subjects are randomized at study entry to initial SLT at standard or low energy. Subjects who reach Month 12 without discontinuing study treatment are randomized a second time to annual low-energy repeat SLT or as-needed standard energy repeat SLT. There are 2 arms in the first 12 months of the study and 2 arms in Months 13-48.
Current deign: Subjects receive standard at SLT at study entry. Subjects who reach Month 12 without discontinuing study treatment are randomized to annual low-energy repeat SLT or as-needed standard energy repeat SLT. There are 2 arms in the first 12 months of the study and 2 arms in Months 13-48.
TREATMENT
NONE
Study Groups
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Trial 1: Initial standard energy SLT
Standard energy SLT is 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.
Standard Energy SLT
SLT performed at standard energy
Trial 2: Month 12 Randomization: Annual Low Energy Repeat SLT
At month 12, eligible subjects will be randomized to undergo repeat SLT either annually at low energy or as needed at standard energy.
Low energy SLT will consist of 100 treatment spots delivered at 0.4 mJ per spot throughout the full 360° treatment, with the exception that energy can be reduced to 0.3 mJ 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.
Low Energy SLT
SLT performed at low energy
Trial 2: Month 12 Randomization: As-Needed Repeat SLT at Standard Energy
At month 12, eligible subjects will be randomized to undergo repeat SLT either annually at low energy or as needed at standard energy.
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.
Standard Energy SLT
SLT performed at standard energy
Trial 1: Initial Low Energy SLT
Note: This arm was discontinued following a planned interim analysis.
Low energy SLT will consist of 100 treatment spots delivered at 0.4 mJ per spot throughout the full 360° treatment, with the exception that energy can be reduced to 0.3 mJ if bubbles are seen with 5 consecutive spots and can be increased back to a maximum of 0.4mJ if no bubbles are seen with 5 consecutive spots.
Low Energy SLT
SLT performed at low energy
Interventions
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Low Energy SLT
SLT performed at low energy
Standard Energy SLT
SLT performed at standard energy
Eligibility Criteria
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Inclusion Criteria
2. Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes):
1. 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)
2. Mild primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation better than -6.0 dB with no points in the central 5° \<15 dB (see figure on next page)
3. Moderate primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation equal to or worse than -6.0 dB but no worse than -12.0 dB and no central 5° points \<15 dB or mean deviation -12.0 dB or better with 1 central 5° points \<15 dB (see figure on next page).
3. Each eye with BCVA 20/200 (UK 6/60) or better
Exclusion Criteria
2. Any history of IOP-lowering laser (prophylactic iridotomy not included) or surgical procedure
3. Advanced POAG in either eye (worse than moderate POAG as defined above)
4. Glaucoma other than POAG (including pigmentary and pseudoexfoliation glaucoma) in either eye
5. Mean IOP \> 35 mmHg at either the screening or baseline visit in either eye
6. Narrow or closed angle (Shaffer Grade 0, 1, or 2) in either eye
7. Contraindications to SLT or any other study intervention
8. Any corneal pathology that would preclude accurate assessment of IOP by Goldmann tonometry in either eye
9. Any intraocular surgical procedure within the past 6 months in either eye
10. Inability to attend all scheduled study visits
11. Pregnant or planning to become pregnant in the next 4 years
18 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
West Virginia University
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Balasubramani Goundappa
Research Associate Professor
Principal Investigators
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Tony Realini, MD, MPH
Role: STUDY_CHAIR
West Virginia University
Goundappa K Balasubramani, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Stephen Wisniewski, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Harvard Eye Associates
Laguna Hills, California, United States
Doheny Eye Center UCLA
Pasadena, California, United States
University of California, Davis
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
Mile High Eye Institute
Sheridan, Colorado, United States
Clear Vue Laser Eye Center
Lakeworth, Florida, United States
Northwestern Medical Group
Chicago, Illinois, United States
Chicago Arbor Eye Institute
Orland Park, Illinois, United States
Illinois Eye Center
Peoria, Illinois, United States
Wilmer Eye Institute Johns Hopkins
Baltimore, Maryland, United States
Massachusetts Eye and Ear
Boston, Massachusetts, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Mark Latina, LLC
Reading, Massachusetts, United States
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, United States
Kresge Eye Institute Wayne State University
Detroit, Michigan, United States
New York Eye Surgery Associates
The Bronx, New York, United States
University Hospitals Eye Institute
Cleveland, Ohio, United States
Cleveland Clinic Cole Eye Institute
Cleveland, Ohio, United States
Devers Eye Institute
Portland, Oregon, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
Scheie Eye Institute
Philadelphia, Pennsylvania, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
UPMC Eye Center
Pittsburgh, Pennsylvania, United States
Vanderbilt Eye Institute
Nashville, Tennessee, United States
Ophthalmology Associates
Fort Worth, Texas, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Ocular Health Centre
Kitchener, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Realini T, Gazzard G, Latina M, Kass M. Low-energy Selective Laser Trabeculoplasty Repeated Annually: Rationale for the COAST Trial. J Glaucoma. 2021 Jul 1;30(7):545-551. doi: 10.1097/IJG.0000000000001788.
Related Links
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Study website
Other Identifiers
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