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NCT04967989PHASE3Recruiting

Clarifying the Optimal Application of SLT Therapy Trial

University of Pittsburgh

Start Date

9/7/2021

Completion Date

8/31/2027

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

PROCEDURE

Low Energy SLT

PROCEDURE

Standard Energy SLT

Interested in This Trial?

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Conditions

Glaucoma and Ocular Hypertension

Locations

Harvard Eye Associates

Laguna Hills, California 92653

United States

Doheny Eye Center UCLA

Pasadena, California 91105

United States

University of California, Davis

Sacramento, California 95817

United States

University of California, San Francisco

San Francisco, California 94158

United States

Mile High Eye Institute

Sheridan, Colorado 80110

United States

Clear Vue Laser Eye Center

Lakeworth, Florida 33467

United States

Northwestern Medical Group

Chicago, Illinois 60615

United States

Chicago Arbor Eye Institute

Orland Park, Illinois 60467

United States

Illinois Eye Center

Peoria, Illinois 61615

United States

Wilmer Eye Institute Johns Hopkins

Baltimore, Maryland 21287

United States

Massachusetts Eye and Ear

Boston, Massachusetts 02114

United States

Ophthalmic Consultants of Boston

Boston, Massachusetts 02451

United States

Mark Latina, LLC

Reading, Massachusetts 01867

United States

University of Michigan Kellogg Eye Center

Ann Arbor, Michigan 48105

United States

Kresge Eye Institute Wayne State University

Detroit, Michigan 48201

United States

New York Eye Surgery Associates

The Bronx, New York 10469

United States

University Hospitals Eye Institute

Cleveland, Ohio 44106

United States

Cleveland Clinic Cole Eye Institute

Cleveland, Ohio 44195

United States

Devers Eye Institute

Portland, Oregon 97210

United States

Eye Care Specialists

Kingston, Pennsylvania 18704

United States

Scheie Eye Institute

Philadelphia, Pennsylvania 19104

United States

Wills Eye Hospital

Philadelphia, Pennsylvania 19107

United States

UPMC Eye Center

Pittsburgh, Pennsylvania 15213

United States

Vanderbilt Eye Institute

Nashville, Tennessee 37232

United States

Ophthalmology Associates

Fort Worth, Texas 76102

United States

Spokane Eye Clinical Research

Spokane, Washington 99204

United States

West Virginia University

Morgantown, West Virginia 26505

United States

University of Wisconsin-Madison

Madison, Wisconsin 53705

United States

Ocular Health Centre

Kitchener, Ontario N2A0K5

Canada