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NCT Number: NCT04967989

Clarifying the Optimal Application of SLT Therapy Trial

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ocular Health Centre, Kitchener, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Energy SLT

Procedure

SLT performed at low energy

Standard Energy SLT

Procedure

SLT performed at standard energy

Primary outcomes

  1. 12-month survival

    Time frame: 12 months

    Survival of first SLT through Month 12

  2. 48-month survival

    Time frame: 48 months

    At Month 12, subjects are randomized to repeat SLT either annually at low energy or PRN at standard energy. The proportion controlled with SLT alone at Month 48 will be compared between groups

Secondary outcomes

  1. Mean IOP

    Time frame: 12 months

    Mean IOP at month 12

  2. Long-term mean IOP

    Time frame: 12, 24, 36, and 48 months

    Mean IOP at each study visit

  3. Incidence of IOP spikes

    Time frame: 0, 12, 24, 36, and 48 months

    IOP spikes > 5 mmHg on day of SLT

Study contacts

Contact information is provided by the study sponsor or research team.

Tony Realini, MD, MPH

CONTACT

[email protected]

3045986926

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Eye Institute (NEI)
  • West Virginia University

Registry information

Acronym: COAST

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2021
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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