Clinical trial NCT04967989: Clarifying the Optimal Application of SLT Therapy Trial
Official title: Clarifying the Optimal Application of SLT Therapy Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma and Ocular Hypertension
Keywords: glaucoma
selective laser trabeculoplasty
clinical trial
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
name: West Virginia University
First posted: 2021-07-20
Enrollment: 790
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The COAST trial underwent a design modification in response to a planned interim analysis. The original and current designs are described here.

Initial Design: Subjects are randomized at study entry to initial SLT at standard or low energy. Subjects who reach Month 12 without discontinuing study treatment are randomized a second time to annual low-energy repeat SLT or as-needed standard energy repeat SLT. There are 2 arms in the first 12 months of the study and 2 arms in Months 13-48.

Current deign: Subjects receive standard at SLT at study entry. Subjects who reach Month 12 without discontinuing study treatment are randomized to annual low-energy repeat SLT or as-needed standard energy repeat SLT. There are 2 arms in the first 12 months of the study and 2 arms in Months 13-48.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 12-month survival
timeFrame: 12 months
measure: 48-month survival
timeFrame: 48 months
Secondary outcomes:
measure: Mean IOP
timeFrame: 12 months
measure: Long-term mean IOP
timeFrame: 12, 24, 36, and 48 months
measure: Incidence of IOP spikes
timeFrame: 0, 12, 24, 36, and 48 months
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Pasadena
country: United States
facility: Doheny Eye Center UCLA
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Sheridan
country: United States
facility: Mile High Eye Institute
state: Colorado
city: Lakeworth
country: United States
facility: Clear Vue Laser Eye Center
state: Florida
city: Chicago
country: United States
facility: Northwestern Medical Group
state: Illinois
city: Orland Park
country: United States
facility: Chicago Arbor Eye Institute
state: Illinois
city: Peoria
country: United States
facility: Illinois Eye Center
state: Illinois
city: Baltimore
country: United States
facility: Wilmer Eye Institute Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts Eye and Ear
state: Massachusetts
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Reading
country: United States
facility: Mark Latina, LLC
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Kellogg Eye Center
state: Michigan
city: Detroit
country: United States
facility: Kresge Eye Institute Wayne State University
state: Michigan
city: Bronx
country: United States
facility: New York Eye Surgery Associates
state: New York
city: Cleveland
country: United States
facility: University Hospitals Eye Institute
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Cole Eye Institute
state: Ohio
city: Portland
country: United States
facility: Devers Eye Institute
state: Oregon
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Philadelphia
country: United States
facility: Scheie Eye Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Eye Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
city: Fort Worth
country: United States
facility: Ophthalmology Associates
state: Texas
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Kitchener
country: Canada
facility: Ocular Health Centre
state: Ontario
Study officials:
affiliation: West Virginia University
name: Tony Realini, MD, MPH
role: STUDY_CHAIR
affiliation: University of Pittsburgh
name: Goundappa K Balasubramani, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Stephen Wisniewski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.