Comparing low energy and standard energy SLT therapy for glaucoma
Clarifying the Optimal Application of SLT Therapy Trial
This study tests if using lower energy for laser treatment can help people with glaucoma manage their eye pressure better and reduce the need for daily eye drops compared to standard energy treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 790 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 29 sites (Laguna Hills, California and 28 other locations) |
| Trial ID | NCT04967989 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the effectiveness of selective laser trabeculoplasty (SLT) performed at low energy compared to standard energy in treating glaucoma and ocular hypertension. It will also investigate whether repeating SLT at low energy annually can better prevent or delay the need for daily eye drop medications compared to waiting for the effects of SLT to diminish. Participants will be monitored for their intraocular pressure and overall eye health throughout the study.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with high-risk ocular hypertension or mild to moderate primary open-angle glaucoma.
Not a fit: Patients with advanced glaucoma or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for glaucoma patients, potentially reducing their reliance on daily medications.
How similar studies have performed: Other studies have shown promising results with SLT therapy, suggesting that this approach may be effective, although the specific low energy application is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Laguna Hills, California and 28 other locations
- Harvard Eye Associates — Laguna Hills, California, United States (Recruiting)
- Doheny Eye Center UCLA — Pasadena, California, United States (Recruiting)
- University of California, Davis — Sacramento, California, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Mile High Eye Institute — Sheridan, Colorado, United States (Recruiting)
- Clear Vue Laser Eye Center — Lakeworth, Florida, United States (Recruiting)
- Northwestern Medical Group — Chicago, Illinois, United States (Recruiting)
- Chicago Arbor Eye Institute — Orland Park, Illinois, United States (Recruiting)
- Illinois Eye Center — Peoria, Illinois, United States (Recruiting)
- Wilmer Eye Institute Johns Hopkins — Baltimore, Maryland, United States (Recruiting)
- Massachusetts Eye and Ear — Boston, Massachusetts, United States (Recruiting)
- Ophthalmic Consultants of Boston — Boston, Massachusetts, United States (Recruiting)
- Mark Latina, LLC — Reading, Massachusetts, United States (Recruiting)
- University of Michigan Kellogg Eye Center — Ann Arbor, Michigan, United States (Recruiting)
- Kresge Eye Institute Wayne State University — Detroit, Michigan, United States (Recruiting)
- New York Eye Surgery Associates — The Bronx, New York, United States (Recruiting)
- University Hospitals Eye Institute — Cleveland, Ohio, United States (Recruiting)
- Cleveland Clinic Cole Eye Institute — Cleveland, Ohio, United States (Recruiting)
- Devers Eye Institute — Portland, Oregon, United States (Recruiting)
- Eye Care Specialists — Kingston, Pennsylvania, United States (Recruiting)
- Scheie Eye Institute — Philadelphia, Pennsylvania, United States (Recruiting)
- Wills Eye Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
- UPMC Eye Center — Pittsburgh, Pennsylvania, United States (Active_not_recruiting)
- Vanderbilt Eye Institute — Nashville, Tennessee, United States (Recruiting)
- Ophthalmology Associates — Fort Worth, Texas, United States (Recruiting)
- Spokane Eye Clinical Research — Spokane, Washington, United States (Recruiting)
- West Virginia University — Morgantown, West Virginia, United States (Recruiting)
- University of Wisconsin-Madison — Madison, Wisconsin, United States (Recruiting)
- Ocular Health Centre — Kitchener, Ontario, Canada (Active_not_recruiting)
Study contacts
- Principal investigator: Goundappa K Balasubramani, PhD — University of Pittsburgh
- Study coordinator: Tony Realini, MD, MPH
- Email: hypotonywvu@gmail.com
- Phone: 3045986926
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.