Clarifying the Optimal Application of SLT Therapy Trial

Glaucoma and Ocular Hypertension Clinical Trial

— COAST  

Official title:

Clarifying the Optimal Application of SLT Therapy Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04967989
• Other study ID #: UG1EY031654
• Status: Recruiting
• Phase: Phase 3
• Start date: September 7, 2021
• Est. completion date: August 31, 2027

Study information

• Verified date: January 2024
• Source: West Virginia University
• Contact: Tony Realini, MD, MPH
• Phone: 3045986926
• Email: hypotonywvu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: August 31, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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) [enrollment of trial participants with High-risk OHT will be capped at 25% of total enrollment]

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

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma and Ocular Hypertension
• Ocular Hypertension

Intervention

Procedure:
• Low Energy SLT
SLT performed at low energy
• Standard Energy SLT
SLT performed at standard energy

Locations

Country	Name	City	State
Canada	Ocular Health Centre	Kitchener	Ontario
United Kingdom	Moorfields Eye Hospital	London
United States	University of Michigan Kellogg Eye Center	Ann Arbor	Michigan
United States	Wilmer Eye Institute Johns Hopkins	Baltimore	Maryland
United States	Massachusetts Eye and Ear	Boston	Massachusetts
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	New York Eye Surgery Associates	Bronx	New York
United States	Northwestern Medical Group	Chicago	Illinois
United States	Cleveland Clinic Cole Eye Institute	Cleveland	Ohio
United States	University Hospitals Eye Institute	Cleveland	Ohio
United States	Kresge Eye Institute Wayne State University	Detroit	Michigan
United States	Ophthalmology Associates	Fort Worth	Texas
United States	Eye Care Specialists	Kingston	Pennsylvania
United States	Harvard Eye Associates	Laguna Hills	California
United States	Clear Vue Laser Eye Center	Lake Worth	Florida
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	West Virginia University	Morgantown	West Virginia
United States	Vanderbilt Eye Institute	Nashville	Tennessee
United States	Arbors Centers for Eye Care	Orland Park	Illinois
United States	Doheny Eye Center UCLA	Pasadena	California
United States	Illinois Eye Center	Peoria	Illinois
United States	Scheie Eye Institute	Philadelphia	Pennsylvania
United States	Wills Eye Hospital	Philadelphia	Pennsylvania
United States	UPMC Eye Center	Pittsburgh	Pennsylvania
United States	Devers Eye Institute	Portland	Oregon
United States	Mark Latina, LLC	Reading	Massachusetts
United States	University of California, Davis	Sacramento	California
United States	University of California, San Francisco	San Francisco	California
United States	Mile High Eye Institute	Sheridan	Colorado
United States	Spokane Eye Clinical Research	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
West Virginia University	University of Pittsburgh

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

References & Publications (1)

Realini T, Gazzard G, Latina M, Kass M. Low-energy Selective Laser Trabeculoplasty Repeated Annually: Rationale for the COAST Trial. J Glaucoma. 2021 Jul 1;30(7):545-551. doi: 10.1097/IJG.0000000000001788. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-month survival	Survival of first SLT through Month 12	12 months
Primary	48-month medication-free survival	At Month 12, subjects are re-randomized to repeat SLT either annually at low energy or PRN at initially-assigned energy. The proportion surviving medication-free at Month 48 will be compared between groups	48 months
Secondary	Mean IOP	Mean IOP at month 12	12 months
Secondary	Long-term mean IOP	Mean IOP at each study visit	12, 24, 36, and 48 months
Secondary	Incidence of IOP spikes	IOP spikes > 5 mmHg on day of SLT	0, 12, 24, 35, and 48 months

External Links

•   Study website