Recruiting

Phase 3

SLT TherapyClarifying the Optimal Application of SLT Therapy Trial

Sponsor:

University of Pittsburgh

Code:

NCT04967989

Conditions

Glaucoma and Ocular Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Low Energy SLT

Standard Energy SLT

Study Details

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.

Conditions

Glaucoma and Ocular Hypertension

Study ID

NCT04967989

Start date

Sep 7, 2021

Status verified date

Aug, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

790 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Low Energy SLT

SLT performed at low energy

Standard Energy SLT

SLT performed at standard energy

Primary outcome measure

12-month survival [ Time Frame: 12 months ]
48-month survival [ Time Frame: 48 months ]

Central Contacts and Locations

Central contacts

Tony Realini, MD, MPH

3045986926 hypotonywvu@gmail.com

Locations

Harvard Eye Associates

Recruiting

Laguna Hills, California, United States, 92653

Contacts

Ashwini Ravichandran

949-951-2020 aravichandran@harvardeye.com

Principal Investigator:

Ye Elaine Wang, MD

Doheny Eye Center UCLA

Recruiting

Pasadena, California, United States, 91105

Contacts

Mayra Raygoza

(626) 817-4747 MRaygoza@mednet.ucla.edu

Principal Investigator:

Judy L Chen, MD

University of California, Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Leslie Valverde

916-734-6302 ldlopez@ucdavis.edu

Principal Investigator:

James Brandt, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Ethan Liang

(415) 525-9890 Ethan.Liang@ucsf.edu

Principal Investigator:

Ying Han, MD

Mile High Eye Institute

Recruiting

Sheridan, Colorado, United States, 80110

Contacts

Michelle Lopez Galindo

(303) 482-1300 Michelle@mhei.com

Principal Investigator:

Zachary Vest, MD

Clear Vue Laser Eye Center

Recruiting

Lakeworth, Florida, United States, 33467

Contacts

Michelle Hill

561-432-4141 michelle@clearvuenow.com

Principal Investigator:

Monique Barbour, MD

Northwestern Medical Group

Recruiting

Chicago, Illinois, United States, 60615

Contacts

Madison Wood

(312) 695-0252 madison.wood@northwestern.edu

Principal Investigator:

Angelo Tanna, MD

Chicago Arbor Eye Institute

Recruiting

Orland Park, Illinois, United States, 60467

Contacts

Lorene Rafol

708-249-1026 lorenerafol@arboreyecare.com

Principal Investigator:

Richard Quinones, MD

Illinois Eye Center

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Lori Hendershott

309-213-0664 lhendershott@illinoiseyecenter.com

Principal Investigator:

Sachin Kalarn, MD

Wilmer Eye Institute Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Rucha Thaker

908- 616-1807 rthaker2@jh.edu

Principal Investigator:

Pradeep Ramulu, MD

Massachusetts Eye and Ear

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Michael Cheung

mcheung0@meei.harvard.edu

Principal Investigator:

Michael Lin, MD

Ophthalmic Consultants of Boston

Recruiting

Boston, Massachusetts, United States, 02451

Contacts

Jessica Placher

(617) 314-2734 jplacher@eyeboston.com

Principal Investigator:

Theodor Sauer, MD

Mark Latina, LLC

Recruiting

Reading, Massachusetts, United States, 01867

Contacts

Ann Gardikas

781-942-9876 anngardikas76@gmail.com

Principal Investigator:

Mark Latina, MD

University of Michigan Kellogg Eye Center

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

Lindsay Rudberg

734-647-9196 rulindsa@med.umich.edu

Principal Investigator:

Amanda Bicket, MD

Kresge Eye Institute Wayne State University

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Bayan El-Haik

313-515-5487 bayan.el-haik@wayne.edu

Principal Investigator:

Bret Hughes, MD

New York Eye Surgery Associates

Recruiting

The Bronx, New York, United States, 10469

Contacts

Krystina Tavarez-Feliciano

347-860-4474 kfeliciano@nyeye.com

Principal Investigator:

Nathan Radcliffe, MD

University Hospitals Eye Institute

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Sangeetha Raghupathy

216-844-8552 Sangeetha.Raghupathy@uhhospitals.org

Principal Investigator:

Douglas Rhee, MD

Cleveland Clinic Cole Eye Institute

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Dusica Vasic

216-445-3840 vasicd@ccf.org

Principal Investigator:

Ang Li, MD

Devers Eye Institute

Recruiting

Portland, Oregon, United States, 97210

Contacts

Jack Rees

503-413-8495 jrees@deverseye.org

Principal Investigator:

Robert Kinast, MD

Eye Care Specialists

Recruiting

Kingston, Pennsylvania, United States, 18704

Contacts

Cheryl Bayley

570-714-5915 cheryl.bayley@vipeyes.com

Principal Investigator:

Daniel Lutz, MD

Scheie Eye Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Criston Young

856-519-8295 Criston.Young@pennmedicine.upenn.edu

Principal Investigator:

Ahmara Ross, MD

Wills Eye Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Meskerem Divers

215-825-4712 MDivers@willseye.org

Principal Investigator:

Lauren Hock, MD

Vanderbilt Eye Institute

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Marybeth Carter

616-936-1639 marybeth.l.carter@vumc.org

Principal Investigator:

Rachel Kuchtey, MD

Ophthalmology Associates

Recruiting

Fort Worth, Texas, United States, 76102

Contacts

Kaitlin Sinclair

940-452-1173 ksinclair@oafw2020.com

Principal Investigator:

Brian Flowers, MD

Spokane Eye Clinical Research

Recruiting

Spokane, Washington, United States, 99204

Contacts

Dylan Waidelich

509-623-9768 dwaidelich@spokaneeye.com

Principal Investigator:

Rory Allar, MD

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26505

Contacts

Athena Echols, LPN

304-598-6977 athena.sparks@wvumedicine.org

Principal Investigator:

Tony Realini, MD, MPH

University of Wisconsin-Madison

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Kelly Boyd

608-265-4589 kmboyd@wisc.edu

Principal Investigator:

Yao Liu, MD

More Information

Sponsor

University of Pittsburgh

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

glaucoma
selective laser trabeculoplasty
clinical trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-08-14.