Clarifying the Optimal Application of SLT Therapy Trial

a study on Glaucoma High Blood Pressure Ocular Hypertension

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Ying Han, MD
Headshot of Ying Han
Ying Han

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.

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. In good health, newly diagnosed and treatment naïve (no prior IOP-lowering treatments), with decision to treat made by an ophthalmologist on the basis of risk profile, patient preference, or both 3. Age 18 years or older 4. Each eye with BCVA at least 20/200 (UK 6/60) 5. Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes):
  2. 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]
  3. Mild primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation >-6.0 dB with no points in the central 5° <15 dB
  4. Moderate primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation -6.0 dB to >-12 dB and no more than 1 central 5° point <15 dB

You CAN'T join if...

  1. Advanced POAG in either eye
  2. Glaucoma other than POAG (including pigmentary and pseudoexfoliation glaucoma) in either eye
  3. Mean IOP > 35 mmHg at either the screening or baseline visit in either eye
  4. Narrow or closed angle (Shaffer Grade 0, 1, or 2) in either eye
  5. Contraindications to SLT, brimonidine, or any other study intervention
  6. Any corneal pathology that would preclude accurate assessment of IOP by Goldmann tonometry in either eye
  7. Any intraocular surgical procedure within the past 6 months in either eye
  8. Inability to attend all scheduled study visits

Locations

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

Lead Scientist at UCSF

  • Ying Han, MD
    Dr. Ying Han is an ophthalmologist who specializes in treating glaucoma, including medical, laser and surgical therapies. She has expertise in evaluating and treating cataracts as well. In her research, Han evaluates new drug delivery and new surgical procedures for glaucoma. She's also interested in screening and treatment of glaucoma to prevent vision loss.

Details

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