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Completed

NCT Number: NCT02023242

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

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

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension Pigmentary Glaucoma Pseudoexfoliative Glaucoma

Age range

45 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Richard Hope at Ivantis

Irvine, California, 92618, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrus Microstent

Device

Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.

iStent Trabecular Micro Bypass

Device

Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.

Primary outcomes

  1. Unmedicated IOP </= 19 mmHg at 12 Months

    Time frame: 12 months

    Percentage of subjects with IOP </= 19 mmHg and without the use of ocular hypotensive medications at 12 months

Secondary outcomes

  1. The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months

    Time frame: 12 & 24 Months

    The percentage of subjects who are not using ocular hypotensive medications at 12 and 24 months

  2. Mean Medication Use at 12 and 24 Months

    Time frame: 12 & 24 Months

    The mean medication use at 12 and 24 months

  3. Unmedicated IOP </= 19 mmHg at 24 Months

    Time frame: 24 Months

    Percentage of subjects with IOP </= 19 mmHg and without the use of ocular hypotensive medications at 24 months

  4. Unmedicated IOP </= 18 mmHg at 12 Months

    Time frame: 12 months

    Percentage of subjects with IOP </= 18 mmHg and without the use of ocular hypotensive medications at 12 months

Sponsors and collaborators

Lead sponsor

Ivantis, Inc.

Industry

Registry information

Official study title

A Prospective, Multicenter, Randomized Comparison of the Hydrus to the iStent® for Lowering Intraocular Pressure in Primary Open Angle Glaucoma

Acronym: COMPARE

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Dec 30, 2013
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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