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Clarifying the Optimal Application of SLT Therapy Trial

NCT04967989 · University of Pittsburgh
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
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.
Eligibility criteria
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) 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 (this is a modification implemented during active enrollment) 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
Study design
Enrollment target: 790 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-09-07
Estimated completion: 2027-08-31
Last updated: 2025-10-02
Interventions
Procedure: Low Energy SLTProcedure: Standard Energy SLT
Primary outcomes
  • 12-month survival (12 months)
  • 48-month survival (48 months)
Sponsor
University of Pittsburgh · other
With: National Eye Institute (NEI), West Virginia University
Contacts & investigators
ContactTony Realini, MD, MPH · contact · hypotonywvu@gmail.com · 3045986926
InvestigatorTony Realini, MD, MPH · study_chair, West Virginia University
InvestigatorGoundappa K Balasubramani, PhD · principal_investigator, University of Pittsburgh
InvestigatorStephen Wisniewski, PhD · principal_investigator, University of Pittsburgh
All locations (29)
Harvard Eye AssociatesRecruiting
Laguna Hills, California, United States
Doheny Eye Center UCLARecruiting
Pasadena, California, United States
University of California, DavisRecruiting
Sacramento, California, United States
University of California, San FranciscoRecruiting
San Francisco, California, United States
Mile High Eye InstituteRecruiting
Sheridan, Colorado, United States
Clear Vue Laser Eye CenterRecruiting
Lakeworth, Florida, United States
Northwestern Medical GroupRecruiting
Chicago, Illinois, United States
Chicago Arbor Eye InstituteRecruiting
Orland Park, Illinois, United States
Illinois Eye CenterRecruiting
Peoria, Illinois, United States
Wilmer Eye Institute Johns HopkinsRecruiting
Baltimore, Maryland, United States
Massachusetts Eye and EarRecruiting
Boston, Massachusetts, United States
Ophthalmic Consultants of BostonRecruiting
Boston, Massachusetts, United States
Mark Latina, LLCRecruiting
Reading, Massachusetts, United States
University of Michigan Kellogg Eye CenterRecruiting
Ann Arbor, Michigan, United States
Kresge Eye Institute Wayne State UniversityRecruiting
Detroit, Michigan, United States
New York Eye Surgery AssociatesRecruiting
The Bronx, New York, United States
University Hospitals Eye InstituteRecruiting
Cleveland, Ohio, United States
Cleveland Clinic Cole Eye InstituteRecruiting
Cleveland, Ohio, United States
Devers Eye InstituteRecruiting
Portland, Oregon, United States
Eye Care SpecialistsRecruiting
Kingston, Pennsylvania, United States
Scheie Eye InstituteRecruiting
Philadelphia, Pennsylvania, United States
Wills Eye HospitalRecruiting
Philadelphia, Pennsylvania, United States
UPMC Eye CenterActive Not Recruiting
Pittsburgh, Pennsylvania, United States
Vanderbilt Eye InstituteRecruiting
Nashville, Tennessee, United States
Ophthalmology AssociatesRecruiting
Fort Worth, Texas, United States
Spokane Eye Clinical ResearchRecruiting
Spokane, Washington, United States
West Virginia UniversityRecruiting
Morgantown, West Virginia, United States
University of Wisconsin-MadisonRecruiting
Madison, Wisconsin, United States
Ocular Health CentreActive Not Recruiting
Kitchener, Ontario, Canada
Clarifying the Optimal Application of SLT Therapy Trial · TrialPath