Open Actively Recruiting

Clarifying the Optimal Application of SLT Therapy Trial

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • 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) [enrollment of trial participants with High-risk OHT will be capped at 25% of total enrollment]
    • 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

Exclusion Criteria:

  • Use of topical IOP-lowering medications for more than 6 cumulative months at any time in the past 5 years
  • 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

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Share:
Study Stats
Protocol No.
23-5035
Category
Eye/Ocular Disorders
Principal Investigator
Contact
Karina Lozano
Location
  • UCLA Pasadena
  • UCLA Westwood
For Providers
NCT No.
NCT04967989
For detailed technical eligibility, visit ClinicalTrials.gov.