RECRUITING
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Clarifying the Optimal Application of SLT Therapy Trial
The goal of this study is to understand if SLT performed at low energy is as effective as SLT performed at standard energy, and also to see if repeating SLT at low energy once a year will prevent or delay the need for daily eye drop medications better than waiting for SLT to wear off before repeating it.
Conditions:
🦠 Glaucoma and Ocular Hypertension
🗓️ Study Start (Actual) 7 September 2021
🗓️ Primary Completion (Estimated) 30 June 2027
✅ Study Completion (Estimated) 31 August 2027
👥 Enrollment (Estimated) 640
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Laguna Hills, California, United States
📍 Pasadena, California, United States
📍 Sacramento, California, United States
📍 San Francisco, California, United States
📍 Sheridan, Colorado, United States
📍 Lake Worth, Florida, United States
📍 Chicago, Illinois, United States
📍 Orland Park, Illinois, United States
📍 Peoria, Illinois, United States
📍 Baltimore, Maryland, United States
📍 Boston, Massachusetts, United States
📍 Boston, Massachusetts, United States
📍 Reading, Massachusetts, United States
📍 Ann Arbor, Michigan, United States
📍 Detroit, Michigan, United States
📍 Bronx, New York, United States
📍 Cleveland, Ohio, United States
📍 Cleveland, Ohio, United States
📍 Portland, Oregon, United States
📍 Kingston, Pennsylvania, United States
📍 Philadelphia, Pennsylvania, United States
📍 Philadelphia, Pennsylvania, United States
📍 Pittsburgh, Pennsylvania, United States
📍 Nashville, Tennessee, United States
📍 Fort Worth, Texas, United States
📍 Spokane, Washington, United States
📍 Morgantown, West Virginia, United States
📍 Madison, Wisconsin, United States
📍 Kitchener, Ontario, Canada
📍 London, United Kingdom
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Age 18 or older and in good health
    • 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) \[enrollment of trial participants with High-risk OHT will be capped at 25% of total enrollment\]
    • 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:

    • 1. Use of topical IOP-lowering medications for more than 6 cumulative months at any time in the past 5 years
    • 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 27 June 2021
  • First Submitted that Met QC Criteria 19 July 2021
  • First Posted 20 July 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 January 2024
  • Last Update Posted 17 January 2024
  • Last Verified January 2024
I'm interested ...!!