NCT04967989 Clarifying the Optimal Application of SLT Therapy Trial
| NCT ID | NCT04967989 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Pittsburgh |
| Condition | Glaucoma and Ocular Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 790 participants |
| Start Date | 2021-09-07 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 790 participants in total. It began in 2021-09-07 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Contact & Investigator
Tony Realini, MD, MPH
STUDY CHAIR
West Virginia University
Frequently Asked Questions
Who can join the NCT04967989 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glaucoma and Ocular Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04967989 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 790 participants.
Is NCT04967989 currently recruiting?
Yes, NCT04967989 is actively recruiting participants. Contact the research team at hypotonywvu@gmail.com for enrollment information.
Where is the NCT04967989 trial being conducted?
This trial is being conducted at Laguna Hills, United States, Pasadena, United States, Sacramento, United States, San Francisco, United States and 11 additional locations.
Who is sponsoring the NCT04967989 clinical trial?
NCT04967989 is sponsored by University of Pittsburgh. The principal investigator is Tony Realini, MD, MPH at West Virginia University. The trial plans to enroll 790 participants.