Randomized Study of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System Versus SLT in Primary Open Angle Glaucoma (VISCO360 Study)

Not Applicable

Terminated

• Conditions: Open-Angle Glaucoma
• Interventions: Device: VISCO360 ab interno canaloplasty surgery; Device: Selective Laser Trabeculoplasty (SLT)

• Registration Number: NCT02928289
• Lead Sponsor: Sight Sciences, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-06
• Study First Submitted QC: 2016-10-07
• Study First Posted: 2016-10-10
• Study Start: 2017-01-23
• Primary Completion: 2019-01-17
• Study Completion: 2019-01-17
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Diagnosed with primary open-angle glaucoma (POAG) in the study eye.
• Pseudophakic with Posterior Chamber IOL (PCIOL)
• Able and willing to attend follow up visits for two years post-operative
• Able and willing to sign informed consent

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Exclusion Criteria

• Phakia or aphakia
• Previous glaucoma procedure with or without an implantable glaucoma device (including incisional surgery, ALT, iridectomy/iridotomy, etc.) [Subjects with one prior SLT application (>3 months prior to screening) or prior ECP (performed > 12 months prior to screening) can be enrolled].
• Use of more than 3 ocular hypotensive medications (combination medications count as 2 medications)
• Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma
• Abnormal angle anatomy as determined by gonioscopy (e.g. peripheral anterior synechiae, rubeosis or other angle abnormalities)
• Participation in any clinical trial ≤ 30 days prior to screening

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VISCO360 ab interno canaloplasty surgery	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).
Selective Laser Trabeculoplasty (SLT)	Selective Laser Trabeculoplasty (SLT)	Subjects randomized to this arm will undergo the SLT procedure.

Primary Outcome Measures

Name	Time	Method
Mean change in diurnal IOP (Measured in mm Hg)	12 months	Measurement is performed at 12 months following wash-out of glaucoma medication

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects achieving a ≥ 20% reduction in mean diurnal IOP	12 months	Measurement is performed at 12 months following wash-out of glaucoma medication

Trial Locations

Locations (6)

Wills Eye Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

El Paso Eye Surgeons; 🇺🇸 El Paso, Texas, United States

Dean McGee Eye Institute; 🇺🇸 Oklahoma City, Oklahoma, United States

Coastal Vision Medical Group; 🇺🇸 Orange, California, United States

Ophthalmology Associates; 🇺🇸 Fort Worth, Texas, United States

Vold Vision; 🇺🇸 Fayetteville, Arkansas, United States