Safety and Effectiveness of the Sight Sciences VISCO™360 Versus SLT in Primary Open Angle Glaucoma

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Sight Sciences, Inc.
Study ID
NCT02928289
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VISCO360 ab interno canaloplasty surgery — DEVICE
    360 degrees of viscodilation of Schlemm's canal
  • Selective Laser Trabeculoplasty (SLT) — DEVICE
    360 degrees of selective laser trabeculoplasty

Study Details

The purpose of this study is to evaluate the safety and effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in reducing intraocular pressure (IOP) in adult, pseudophakic subjects with open-angle glaucoma.

Key Dates

Start date
Jan 23, 2017
Status verified
Oct 2025
Primary completion
Jan 17, 2019
Completion
Jan 17, 2019

Study Design

Enrollment
29 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: VISCO360 ab interno canaloplasty surgery
    Subjects randomized to this arm will undergo a surgical procedure in which the VISCO360 Viscosurgical System will be used to microcatheterize and viscodilate Schlemm's canal (i.e., canaloplasty).
  • Active Comparator: Selective Laser Trabeculoplasty (SLT)
    Subjects randomized to this arm will undergo the SLT procedure.

Primary Outcome Measure

Mean Change From Baseline in Diurnal IOP at 12 Months (Measured in mm Hg) [ Time Frame: 12 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
Vold VisionFayettevilleArkansas72704-
Coastal Vision Medical GroupOrangeCalifornia92868-
Dean McGee Eye InstituteOklahoma CityOklahoma73104-
Wills Eye HospitalPhiladelphiaPennsylvania19107-
El Paso Eye SurgeonsEl PasoTexas79902-
Ophthalmology AssociatesFort WorthTexas76102-

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