Prospective Evaluation of Open-Angle Glaucoma Subjects on... | NCT01252862

Studies
Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents

NCT01252862

Sponsor

Glaukos Corporation

Status

Completed

Last Update Posted

Dec 18, 2017Actual

Enrollment

40Estimated

Phase

Phase 4

Conditions

Subjects With Primary Open-angle Glaucoma (POAG)

Interventions

iStent

Countries

Armenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010Actual

Primary Completion Date

Jul 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Dec 1, 2010

First Submission Date that Met QC Criteria

Dec 2, 2010

First Posted Date

Dec 3, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2017

Last Update Posted Date

Dec 18, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma

Detailed Description

This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Two iStents devices	Experimental	Two iStents devices will be implanted	Device: iStent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iStent	Device	Implantation of two iStents through a small temporal clear corneal incision	Two iStents devices

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs baseline		12 Months

Secondary Outcomes

Measure	Description	Time Frame
IOP < 18 mm Hg at Month 12		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with primary open-angle glaucoma (POAG)
Subject on one topical hypotensive medication

Exclusion Criteria:

Traumatic, uveitic, neovascular, or angle closure glaucoma
Fellow eye already enrolled

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
S.V. Malayan's Ophthalmology Centre		Yerevan		375108	Armenia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26604675	Background	Donnenfeld ED, Solomon KD, Voskanyan L, Chang DF, Samuelson TW, Ahmed II, Katz LJ. A prospective 3-year follow-up trial of implantation of two trabecular microbypass stents in open-angle glaucoma. Clin Ophthalmol. 2015 Nov 3;9:2057-65. doi: 10.2147/OPTH.S91732. eCollection 2015.

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases