Clarifying the Optimal Application of SLT Therapy Trial

Who is this study for? Patients with glaucoma and ocular hypertension
What treatments are being studied? SLT
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

⁃ 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

Locations
United States
California
Harvard Eye Associates
RECRUITING
Laguna Hills
Doheny Eye Center UCLA
RECRUITING
Pasadena
University of California, Davis
RECRUITING
Sacramento
University of California, San Francisco
RECRUITING
San Francisco
Colorado
Mile High Eye Institute
RECRUITING
Sheridan
Florida
Clear Vue Laser Eye Center
RECRUITING
Lakeworth
Illinois
Northwestern Medical Group
RECRUITING
Chicago
Chicago Arbor Eye Institute
RECRUITING
Orland Park
Illinois Eye Center
RECRUITING
Peoria
Massachusetts
Massachusetts Eye and Ear
RECRUITING
Boston
Ophthalmic Consultants of Boston
RECRUITING
Boston
Mark Latina, LLC
RECRUITING
Reading
Maryland
Wilmer Eye Institute Johns Hopkins
RECRUITING
Baltimore
Michigan
University of Michigan Kellogg Eye Center
RECRUITING
Ann Arbor
Kresge Eye Institute Wayne State University
RECRUITING
Detroit
New York
New York Eye Surgery Associates
RECRUITING
The Bronx
Ohio
Cleveland Clinic Cole Eye Institute
RECRUITING
Cleveland
University Hospitals Eye Institute
RECRUITING
Cleveland
Oregon
Devers Eye Institute
RECRUITING
Portland
Pennsylvania
Eye Care Specialists
RECRUITING
Kingston
Scheie Eye Institute
RECRUITING
Philadelphia
Wills Eye Hospital
RECRUITING
Philadelphia
UPMC Eye Center
ACTIVE_NOT_RECRUITING
Pittsburgh
Tennessee
Vanderbilt Eye Institute
RECRUITING
Nashville
Texas
Ophthalmology Associates
RECRUITING
Fort Worth
Washington
Spokane Eye Clinical Research
RECRUITING
Spokane
Wisconsin
University of Wisconsin-Madison
RECRUITING
Madison
West Virginia
West Virginia University
RECRUITING
Morgantown
Other Locations
Canada
Ocular Health Centre
ACTIVE_NOT_RECRUITING
Kitchener
Contact Information
Primary
Tony Realini, MD, MPH
hypotonywvu@gmail.com
3045986926
Time Frame
Start Date: 2021-09-07
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 790
Treatments
Active_comparator: Trial 1: Initial standard energy SLT
Standard energy SLT is performed as follows: beginning at 0.8 mJ, energy will be titrated up or down within the first 5-10 spots until champagne bubbles are visualized with every 2nd or 3rd spot. Energy can be titrated throughout the procedure, in response to variations in pigmentation, to ensure the appearance of champagne bubbles with every 2nd or 3rd spot throughout the full 360° treatment. Energy should be increased if no bubbles are seen with 5 consecutive spots and decreased if bubbles are seen with 5 consecutive spots.
Experimental: Trial 2: Month 12 Randomization: Annual Low Energy Repeat SLT
At month 12, eligible subjects will be randomized to undergo repeat SLT either annually at low energy or as needed at standard energy.~Low energy SLT will consist of 100 treatment spots delivered at 0.4 mJ per spot throughout the full 360° treatment, with the exception that energy can be reduced to 0.3 mJ if bubbles are seen with 5 consecutive spots and can be increased back to a maximum of 0.4mJ is no bubbles are seen with 5 consecutive spots.
Active_comparator: Trial 2: Month 12 Randomization: As-Needed Repeat SLT at Standard Energy
At month 12, eligible subjects will be randomized to undergo repeat SLT either annually at low energy or as needed at standard energy.~Standard SLT will be performed as follows: beginning at 0.8 mJ, energy will be titrated up or down within the first 5-10 spots until champagne bubbles are visualized with every 2nd or 3rd spot. Energy can be titrated throughout the procedure, in response to variations in pigmentation, to ensure the appearance of champagne bubbles with every 2nd or 3rd spot throughout the full 360° treatment. Energy should be increased if no bubbles are seen with 5 consecutive spots and decreased if bubbles are seen with 5 consecutive spots.
Experimental: Trial 1: Initial Low Energy SLT
Note: This arm was discontinued following a planned interim analysis.~Low energy SLT will consist of 100 treatment spots delivered at 0.4 mJ per spot throughout the full 360° treatment, with the exception that energy can be reduced to 0.3 mJ if bubbles are seen with 5 consecutive spots and can be increased back to a maximum of 0.4mJ if no bubbles are seen with 5 consecutive spots.
Sponsors
Leads: University of Pittsburgh
Collaborators: National Eye Institute (NEI), West Virginia University

This content was sourced from clinicaltrials.gov