RECRUITING

Clarifying the Optimal Application of SLT Therapy Trial

Conditions

Glaucoma and Ocular Hypertension glaucoma selective laser trabeculoplasty clinical trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Clarifying the Optimal Application of SLT Therapy Trial

Quick Facts

Study Start:2021-09-07

Study Completion:2027-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04967989

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	1. Use of topical IOP-lowering medications for more than 6 cumulative months at any time in the past 5 years 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

Inclusion Criteria

Exclusion 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

1. Use of topical IOP-lowering medications for more than 6 cumulative months at any time in the past 5 years
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

Contacts and Locations

Study Contact

Tony Realini, MD, MPH

CONTACT

3045986926

hypotonywvu@gmail.com

Principal Investigator

Tony Realini, MD, MPH

STUDY_CHAIR

West Virginia University

Goundappa K Balasubramani, PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Stephen Wisniewski, PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

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

Arbors Centers for Eye Care

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

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

Collaborators and Investigators

Sponsor: West Virginia University

Tony Realini, MD, MPH, STUDY_CHAIR, West Virginia University
Goundappa K Balasubramani, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh
Stephen Wisniewski, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-07

Study Completion Date2027-08-31

Study Record Updates

Study Start Date2021-09-07

Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

glaucoma
selective laser trabeculoplasty
clinical trial

Additional Relevant MeSH Terms

Glaucoma and Ocular Hypertension