Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes

Not Applicable

Completed

• Conditions: Primary Open Angle Glaucoma; Pseudoexfoliative Glaucoma; Pigmentary Glaucoma
• Interventions: Device: Hydrus Microstent; Device: iStent Trabecular Micro Bypass

• Registration Number: NCT02023242
• Lead Sponsor: Ivantis, Inc.

Brief Summary

This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients.

Detailed Description

This is a prospective, multicenter, single-masked, randomized clinical trial comparing the Hydrus Microstent to two iStent implants for the reduction of intraocular pressure in phakic patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma. Post-operative follow-up visits will be conducted at regular intervals.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-12-23
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-30
• Primary Completion: 2017-08
• Study Completion: 2018-01
• Results First Submitted: 2019-10-18
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-25
• Last Update Submitted: 2019-11-25
• Results First Posted: 2019-12-10
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary glaucoma (PG)
• A phakic lens with BCVA of 20/30 or better

Exclusion Criteria

• Forms of primary or secondary glaucoma not listed above
• Prior glaucoma surgery in the study eye

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrus Microstent	Hydrus Microstent	Patients randomized to the Hydrus Microstent .
iStent Trabecular Micro Bypass	iStent Trabecular Micro Bypass	Patients randomized to the iStent Trabecular Micro Bypass

Primary Outcome Measures

Name	Time	Method
Unmedicated IOP </= 19 mmHg at 12 Months	12 months	Percentage of subjects with IOP \</= 19 mmHg and without the use of ocular hypotensive medications at 12 months

Secondary Outcome Measures

Name	Time	Method
Unmedicated IOP </= 19 mmHg at 24 Months	24 Months	Percentage of subjects with IOP \</= 19 mmHg and without the use of ocular hypotensive medications at 24 months
Unmedicated IOP </= 18 mmHg at 12 Months	12 months	Percentage of subjects with IOP \</= 18 mmHg and without the use of ocular hypotensive medications at 12 months
The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months	12 & 24 Months	The percentage of subjects who are not using ocular hypotensive medications at 12 and 24 months
Mean Medication Use at 12 and 24 Months	12 & 24 Months	The mean medication use at 12 and 24 months

Trial Locations

Locations (1)

Contact Richard Hope at Ivantis; 🇺🇸 Irvine, California, United States