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 III

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

In good health, newly diagnosed and treatment naïve (no prior IOP-lowering treatments), with decision to treat made by an ophthalmologist on the basis of risk profile, patient preference, or both 3. Age 18 years or older 4. Each eye with BCVA at least 20/200 (UK 6/60) 5. 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 >-6.0 dB with no points in the central 5° <15 dB
Moderate primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation -6.0 dB to >-12 dB and no more than 1 central 5° point <15 dB

Exclusion Criteria:

Advanced POAG in either eye
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, brimonidine, 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

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