Clarifying the Optimal Application of SLT Therapy Trial

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Age 18 or older and in good health
• 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)
  • 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)
  • 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).
• Each eye with BCVA 20/200 (UK 6/60) or better

🚫 You may not be able to join if…

• 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)
• Any history of IOP-lowering laser (prophylactic iridotomy not included) or surgical procedure
• Advanced POAG in either eye (worse than moderate POAG as defined above)
• 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 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
• Pregnant or planning to become pregnant in the next 4 years

Where this trial is running

• 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

+ 17 more sites.

Who to contact

Tony Realini, MD, MPH · 3045986926 · hypotonywvu@gmail.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04967989.