Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents

Open-Angle Glaucoma Clinical Trial

Official title:

A Prospective Evaluation of Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents and a Postoperative Prostaglandin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456390
• Other study ID #: GCF-023
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: March 26, 2019

Study information

• Verified date: September 2022
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.

Description:

Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 26, 2019
• Est. primary completion date: March 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)
• Open-angle glaucoma (including pseudoexfoliative)

Exclusion Criteria:

• Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)
• Prior ALT
• Prior SLT within 90 days of screening visit

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open-Angle Glaucoma

Intervention

Device:
• iStent and iStent supra
Implantation of two iStent devices and one iStent supra device

Locations

Country	Name	City	State
Armenia	S.V. Malayan Ophthalmological Center	Yerevan

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Country where clinical trial is conducted

Armenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety/adverse event monitoring	Rate of ocular adverse events through 61 months; Findings from IOP, best corrected visual acuity, visual field, specular microscopy measurements; Findings from slit-lamp, fundus and gonioscopic examinations	0-61 months
Primary	Subjects observed at Month 12 who experience a mean medicated diurnal IOP reduction of = 20% vs. baseline mean diurnal IOP	Primary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP reduction of = 20% vs. baseline mean diurnal IOP, had no glaucoma surgical procedures (incisional or laser surgery prior to the 12 month visit), and no postoperative procedure to reposition or remove the stent prior to the 12 month visit, or additional ocular hypotensive medications within 4 weeks of the Month 12 visit	12 Months
Secondary	Mean diurnal IOP < 18mm Hg	Secondary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP < 18 mmHg, had no glaucoma surgical procedures (incisional or laser surgery) prior to the 12 month visit, and no postoperative procedure to reposition or remove the stent prior to the 12 month visit or additional ocular hypotensive medications within 4 weeks of the Month 12 visit	12 months