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Recruiting NCT04967989

Clarifying the Optimal Application of SLT Therapy Trial

Phase III Interventional Glaucoma and Ocular Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low Energy SLT, Standard Energy SLT.
Who it may be relevant to
Registry conditions: Glaucoma and Ocular Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • 12-month survival [Time frame: 12 months]
  • 48-month survival [Time frame: 48 months]
Secondary outcome measures (3)
  • Mean IOP [Time frame: 12 months]
  • Long-term mean IOP [Time frame: 12, 24, 36, and 48 months]
  • Incidence of IOP spikes [Time frame: 0, 12, 24, 36, and 48 months]

Eligibility criteria

Inclusion criteria

  • Age 18 or older and in good health
  • Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes):
  • 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)
  • 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)
  • 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).
  • Each eye with BCVA 20/200 (UK 6/60) or better

Exclusion criteria

  • 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)
  • Any history of IOP-lowering laser (prophylactic iridotomy not included) or surgical procedure
  • Advanced POAG in either eye (worse than moderate POAG as defined above)
  • Glaucoma other than POAG (including pigmentary and pseudoexfoliation glaucoma) in either eye
  • Mean IOP > 35 mmHg at either the screening or baseline visit in either eye
  • Narrow or closed angle (Shaffer Grade 0, 1, or 2) in either eye
  • Contraindications to SLT or any other study intervention
  • Any corneal pathology that would preclude accurate assessment of IOP by Goldmann tonometry in either eye
  • Any intraocular surgical procedure within the past 6 months in either eye
  • Inability to attend all scheduled study visits
  • Pregnant or planning to become pregnant in the next 4 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 28 centers
  • Harvard Eye Associates — Laguna Hills
  • Doheny Eye Center UCLA — Pasadena
  • University of California, Davis — Sacramento
  • University of California, San Francisco — San Francisco
  • Mile High Eye Institute — Sheridan
  • Clear Vue Laser Eye Center — Lakeworth
  • Northwestern Medical Group — Chicago
  • Chicago Arbor Eye Institute — Orland Park
  • … and 20 more centers
Canada · 1 center
  • Ocular Health Centre — Kitchener

Publications

  • 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. PMID 33428350

Identifiers

NCT: NCT04967989 · STUDY21060171 · UG1EY031651 · UG1EY031654 · STUDY21080018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗