Randomized Study of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System Versus SLT in Primary Open Angle Glaucoma (VISCO360 Study)
Status: | Terminated |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 22 - Any |
Updated: | 3/2/2019 |
Start Date: | January 23, 2017 |
End Date: | January 17, 2019 |
Multi-Center, Prospective, Randomized, Controlled Clinical Evaluation of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in Canaloplasty Versus Selective Laser Trabeculoplasty in the Reduction of IOP in Primary Open Angle Glaucoma
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.
VISCO™360 Viscosurgical System in reducing intraocular pressure (IOP) in adult, pseudophakic
subjects with open-angle glaucoma.
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
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