Safety and Effectiveness of the Sight Sciences VISCO™360 Versus SLT in Primary Open Angle Glaucoma
NCT ID: NCT02928289
Last Updated: 2025-11-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
29 participants
INTERVENTIONAL
2017-01-23
2019-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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).
VISCO360 ab interno canaloplasty surgery
360 degrees of viscodilation of Schlemm's canal
Selective Laser Trabeculoplasty (SLT)
Subjects randomized to this arm will undergo the SLT procedure.
Selective Laser Trabeculoplasty (SLT)
360 degrees of selective laser trabeculoplasty
Interventions
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VISCO360 ab interno canaloplasty surgery
360 degrees of viscodilation of Schlemm's canal
Selective Laser Trabeculoplasty (SLT)
360 degrees of selective laser trabeculoplasty
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
22 Years
ALL
No
Sponsors
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Sight Sciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Anne-Marie Ripley
Role: STUDY_DIRECTOR
Sight Sciences, Inc.
Locations
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Vold Vision
Fayetteville, Arkansas, United States
Coastal Vision Medical Group
Orange, California, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
El Paso Eye Surgeons
El Paso, Texas, United States
Ophthalmology Associates
Fort Worth, Texas, United States
Countries
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References
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Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SIGHTVISCO-001
Identifier Type: -
Identifier Source: org_study_id