Clinical Trials Logo
  1. Home
  2. Primary Open Angle Glaucoma
  3. NCT02024464
  4. Details
NCT02024464 Clinical Trial

Comparing Hydrus Microstent(TM) to the iStent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery

Primary Open Angle Glaucoma Clinical Trial

Official title:
A Prospective, Multicenter, Randomized Comparison of the Hydrus Microstent to the iStent for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02024464
Other study ID # CP-10-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2011
Est. completion date August 2018

Study information
Verified date May 2024
Source Ivantis, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients. One of the two devices will be implanted immediately following cataract surgery and the placement of a posterior chamber intra-ocular lens. Only one eye (study eye) will be implanted.

Description:

This is a prospective, multicenter, single-masked, randomized clinical trial comparing Cataract Extraction (CE) + Hydrus Microstent to CE surgery + iStent implant for the reduction of intraocular pressure in patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma with an operable cataract. Eligible patients will be scheduled for cataract surgery. At the conclusion of successful cataract surgery and the placement of a posterior-chamber IOL, qualified subjects will be randomized to receive either the Hydrus Microstent or the iStent implant. Post-operative follow-up visits will be conducted at regular intervals.

Recruitment information / eligibility
Status Completed
Enrollment 306
Est. completion date August 2018
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary dispersion glaucoma (PDG) - An operable age-related cataract with BCVA of 20/40 or worse, eligible for phacoemulsification. Exclusion Criteria: - Forms of primary or secondary glaucoma not listed above - Prior glaucoma surgery in the study eye

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Hydrus Microstent
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
• iStent Trabecular Micro Bypass
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
Procedure:
• Cataract removal and intraocular lens (IOL) implantation
Cataract removal with phacoemulsification using standard techniques, followed by implantation with a posterior-chamber IOL suitable for glaucoma subjects

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ivantis, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12 Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications. Month 12: 8 am, 12 pm, 4 pm
Secondary Percentage of Subjects With 20% Reduction From Baseline in Unmedicated DIOP at Month 12 Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications. Month 12: 8 am, 12 pm, and 4 pm
Secondary Percentage of Subjects With Unmedicated DIOP of Not Less Than 5 mmHg and Not More Than 18 mmHg at Month 12 Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications. Month 12: 8 am, 12 pm, 4 pm
See also
  Status Clinical Trial Phase
Recruiting NCT05564091 - Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma N/A
Recruiting NCT02792803 - A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma Phase 4
Terminated NCT02801617 - Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension Phase 3
Completed NCT01384149 - EXTERNAL SLT Treatment in Patients With Uncontrolled OPEN ANGLE GLAUCOMA Phase 1
Completed NCT00300079 - Study of the Intraocular Pressure (IOP)-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% in Patients With Glaucoma or Ocular Hypertension Phase 4
Enrolling by invitation NCT00221923 - African Descent and Glaucoma Evaluation Study
Recruiting NCT05605743 - Alternate Nostril Breathing Training in Geriatrics With Glaucoma and High Blood Pressure N/A
Completed NCT04828057 - Preservative-free Fixed-dose Combination of Tafluprost 0.0015% / Timolol 0.5% in Patients With Open-angle Glaucoma or Ocular Hypertension: Clinical Effectiveness, Tolerability and Safety in a Real World Setting
Completed NCT01442896 - STudy to Assess Rapid Disease Progression by Clinical and Genetic Factors In Glaucoma patientS That Are High Risk
Enrolling by invitation NCT05557721 - Uddevalla Skövde Transscleral Micropulse Study
Recruiting NCT04595227 - Glaucoma Screening Using Dynamic Analysis of Computerized Pupillary Light Reflex Assessment Device
Terminated NCT04141865 - Effect of Xen Implantation on the Aqueous Humor Proteome
Completed NCT01979913 - An Open, Non-randomized Pilot Study on the Effect of Preservative Free Tafluprost (Saflutan® Augentropfen) in Patients With Ocular Hypertension or Primary Open Angle Glaucoma With an Uncontrolled Intraocular Pressure of 30 mmHg and More Phase 4
Completed NCT01943721 - A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension Phase 1
Completed NCT01769521 - Relationship Between 24-hour IOP Pattern and the 24-hour Blood Pressure Pattern in Patients With POAG N/A
Not yet recruiting NCT01711177 - Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma N/A
Completed NCT02023242 - Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes N/A
Recruiting NCT00773877 - Comparison of Retinal Nerve Fiber Layer (RNFL) Thickness Measurements by Time-Domain and Spectral-Domain OCT In Glaucoma Patients N/A
Recruiting NCT00773123 - Efficacy of Retinal Nerve Fiber Layer (RNFL) / Ganglion Cell Layer Thickness Ratio by RT-View Utilizing Spectral -Domain Technology as a Diagnostic Predictor of Glaucoma. N/A
Completed NCT02544646 - Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG N/A