TerminatedPhase 1/2

Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension

Stopped: Lack of funding

Philippines35 participantsStarted 2013-11

Plain-language summary

The primary purpose of this study is to investigate the safety and efficacy of bilateral DWT in subjects with POAG or OHT compared to active and sham controls. The secondary purpose of the study is to investigate the durability, repeatability, and does response of the same.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Optic disc or retinal nerve fiber layer structural abnormalities (substantiated by OCT); and/or
✓. Visual field abnormality (substantiated with the Humphrey automated perimeter using the SITA Standard 24-2 testing algorithm. Mean deviation (MD) score must be -15dB \< MD \< 0dB.
✓. Greater than or equal to 18mmHg at the Screening Visit or have documented history of IOP being greater than or equal to 22mmHg;
✓. Greater than or equal to 22mmHg at both Eligibility Visits.

What they're measuring

Percent decrease in IOP and change in dependence on IOP-lowering medications from baseline

Timeframe: 6 months

Intra-procedural and post-procedural adverse events

Timeframe: 6 months

Trial details

NCT IDNCT02226094

SponsorOcuTherix, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-06

View on ClinicalTrials.gov More Primary Open-angle Glaucoma (POAG) trials