Safety and Effectiveness of the Sight Sciences VISCOâ„¢360 Versus SLT in Primary Open Angle Glaucoma (NCT02928289) | Clinical Trial Compass
TerminatedNot Applicable
Safety and Effectiveness of the Sight Sciences VISCOâ„¢360 Versus SLT in Primary Open Angle Glaucoma
Stopped: Poor enrollment
United States29 participantsStarted 2017-01-23
Plain-language summary
The purpose of this study is to evaluate the safety and effectiveness of the Sight Sciences VISCOâ„¢360 Viscosurgical System in reducing intraocular pressure (IOP) in adult, pseudophakic subjects with open-angle glaucoma.
Who can participate
Age range22 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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
What they're measuring
1
Mean Change From Baseline in Diurnal IOP at 12 Months (Measured in mm Hg)