Clarifying the Optimal Application of SLT Therapy Trial

Last updated: March 12, 2025
Sponsor: West Virginia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ocular Hypertension

Glaucoma

Treatment

Low Energy SLT

Standard Energy SLT

Clinical Study ID

NCT04967989
UG1EY031654
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  1. Age 18 or older and in good health

  2. Each eye with one of the following qualifying diagnoses (diagnoses may differbetween eyes):

  3. High-risk ocular hypertension (OHT): IOP > 21 mmHg without glaucomatous opticneuropathy (excavation, diffuse or focal thinning or notching of theneuroretinal rim, visible nerve fiber layer defects, or asymmetry of thevertical cup-to-disc ratio of >0.2 between eyes)

  4. Mild primary open-angle glaucoma: glaucomatous optic neuropathy, visual fieldmean deviation better than -6.0 dB with no points in the central 5° <15 dB (seefigure on next page)

  5. Moderate primary open-angle glaucoma: glaucomatous optic neuropathy, visualfield mean deviation equal to or worse than -6.0 dB but no worse than -12.0 dBand no central 5° points <15 dB or mean deviation -12.0 dB or better with 1central 5° points <15 dB (see figure on next page).

  6. Each eye with BCVA 20/200 (UK 6/60) or better

Exclusion

Exclusion Criteria:

  1. Use of topical IOP-lowering medications for more than 6 cumulative months at anytime in the past 5 years (this is a modification implemented during activeenrollment)

  2. Any history of IOP-lowering laser (prophylactic iridotomy not included) or surgicalprocedure

  3. Advanced POAG in either eye (worse than moderate POAG as defined above)

  4. Glaucoma other than POAG (including pigmentary and pseudoexfoliation glaucoma) ineither 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 Goldmanntonometry 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

Total Participants: 790
Treatment Group(s): 2
Primary Treatment: Low Energy SLT
Phase:
Study Start date:
September 07, 2021
Estimated Completion Date:
August 31, 2027

Connect with a study center

  • Ocular Health Centre

    Kitchener, Ontario N2A0K5
    Canada

    Active - Recruiting

  • Moorfields Eye Hospital

    London,
    United Kingdom

    Site Not Available

  • Harvard Eye Associates

    Laguna Hills, California 92653
    United States

    Active - Recruiting

  • Doheny Eye Center UCLA

    Pasadena, California 91105
    United States

    Active - Recruiting

  • University of California, Davis

    Sacramento, California 95817
    United States

    Active - Recruiting

  • University of California, San Francisco

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Mile High Eye Institute

    Sheridan, Colorado 80110
    United States

    Active - Recruiting

  • Clear Vue Laser Eye Center

    Lake Worth, Florida 33467
    United States

    Site Not Available

  • Clear Vue Laser Eye Center

    Lakeworth, Florida 33467
    United States

    Active - Recruiting

  • Northwestern Medical Group

    Chicago, Illinois 60615
    United States

    Active - Recruiting

  • Arbors Centers for Eye Care

    Orland Park, Illinois 60467
    United States

    Active - Recruiting

  • Illinois Eye Center

    Peoria, Illinois 61615
    United States

    Active - Recruiting

  • Wilmer Eye Institute Johns Hopkins

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Massachusetts Eye and Ear

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts 02451
    United States

    Active - Recruiting

  • Mark Latina, LLC

    Reading, Massachusetts 01867
    United States

    Active - Recruiting

  • University of Michigan Kellogg Eye Center

    Ann Arbor, Michigan 48105
    United States

    Active - Recruiting

  • Kresge Eye Institute Wayne State University

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • New York Eye Surgery Associates

    Bronx, New York 10469
    United States

    Active - Recruiting

  • Cleveland Clinic Cole Eye Institute

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • University Hospitals Eye Institute

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Devers Eye Institute

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Eye Care Specialists

    Kingston, Pennsylvania 18704
    United States

    Active - Recruiting

  • Scheie Eye Institute

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Wills Eye Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • UPMC Eye Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Vanderbilt Eye Institute

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Ophthalmology Associates

    Fort Worth, Texas 76102
    United States

    Active - Recruiting

  • Spokane Eye Clinical Research

    Spokane, Washington 99204
    United States

    Active - Recruiting

  • West Virginia University

    Morgantown, West Virginia 26505
    United States

    Active - Recruiting

  • University of Wisconsin-Madison

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

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