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a study on Glaucoma High Blood Pressure Ocular Hypertension

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
completion around
Principal Investigator
by James Brandt, MD

Description

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.

Official Title

Clarifying the Optimal Application of SLT Therapy Trial

Keywords

Glaucoma and Ocular Hypertension, glaucoma, selective laser trabeculoplasty, clinical trial, Ocular Hypertension, Low Energy SLT

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

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

Locations

  • University of California, Davis accepting new patients
    Sacramento California 95817 United States
  • University of California, San Francisco accepting new patients
    San Francisco California 94158 United States

Lead Scientist at UC Davis

  • James Brandt, MD
    Professor, MED: Eye Center, School of Medicine. Authored (or co-authored) 110 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
West Virginia University
Links
Study website Sign up for this study
ID
NCT04967989
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 640 study participants
Last Updated
Contact us about this trial