Clarifying the Optimal Application of SLT Therapy Trial

About

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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