Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One iStent and One iStent Supra

Glaukos

Status: Completed

Conditions: Glaucoma, Open-Angle

Treatments: Device: Cataract surgery plus one iStent and one iStent Supra implanted

Study type: Interventional

Funder types: Industry

Identifiers

NCT03255785

GCF-040

Details and patient eligibility

About

Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular micro-bypass stent and one suprachoroidal stent

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically significant cataract requiring surgery Primary open-angle or pseudoexfoliative glaucoma Visual field defects no worse than -12dB Subject on two ocular hypotensive medications at screening Medicated IOP at screening between 18 and 30 mm Hg Normal iridocorneal anatomy Absence of peripheral anterior synechiae

Exclusion criteria

• Monocular subjects or those with wore than 20/200 vision in fellow eye Prior stent implantation, incision glaucoma surgery, or laser trabeculoplasty in study eye Traumatic, uveitic, or neovascular glaucoma

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

G1 plus G3 with phaco

Experimental group

Description:

Cataract surgery via phacoemulsification followed by implantation of one iStent and one iStent Supra

Treatment:

Device: Cataract surgery plus one iStent and one iStent Supra implanted