Health Trials

Clarifying the Optimal Application of SLT Therapy Trial

ConditionGlaucoma and Ocular Hypertension
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh

About this 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.

Eligibility criteria

Qualifiers

Age 18 or older and in good health

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).

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Low Energy SLT
  • Standard Energy SLT

Treatment groups

790 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Pittsburgh

Lead sponsor

National Eye Institute (NEI)

Collaborator

West Virginia University

Collaborator

Source ClinicalTrials.gov