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Early Feasibility Study of the Brown Glaucoma Implant in Patients With No Light Perceived (Early Bird)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03469297
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : August 15, 2018
Information provided by (Responsible Party):

Brief Summary:
This is a prospective, non-randomized, single-arm early feasibility study to assess the safety and feasibility of lowering intraocular pressure with the Brown Glaucoma Implant. A total of 10 subjects will be enrolled at a single center. Subjects will be followed for 24 months, with the primary assessments completed 6 months after implant.

Condition or disease Intervention/treatment Phase
Glaucoma Device: Brown Glaucoma Implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Feasibility Study of the Brown Glaucoma Implant in Patients With No Light Perceived
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Brown Glaucoma Implant Device: Brown Glaucoma Implant
The Brown Glaucoma Implant (BGI) is an implantable device designed to lower intraocular pressure (IOP) in glaucoma patients by shunting aqueous humor from the anterior chamber of the eye to the surface of the eye. Because there are no physiologic sources of outflow resistance, the device can be engineered to target an IOP that is low enough to halt the progression to blindness in a patient suffering from glaucoma.

Primary Outcome Measures :
  1. Overall Responder Rate [ Time Frame: 6 Months ]
    Responder rate defined as achieving at least 20% reduction from baseline in intra-ocular pressure (IOP)

  2. Adverse Event Rate [ Time Frame: 6 Months ]
    Rate of all AEs

Secondary Outcome Measures :
  1. Mean Change from Baseline in IOP [ Time Frame: 6 Months ]
  2. Alternative Responder Rate [ Time Frame: 6 Months ]
    Responder rate defined as achieving follow-up IOP less than or equal to 14mmHg

  3. Change in IOP-lowering Medications [ Time Frame: 6 Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 22 years and older
  • No light perception in the study eye.
  • Intraocular pressure in the study eye greater than or equal to 15mmHg and less than or equal to 40mmHg
  • At least two contiguous clock hours of intact conjunctiva near the limbus between clock hours of 9:00 and 3:00 in the study eye
  • Adequate space in the anterior chamber of the study eye sufficient to support implant with the BGI
  • Able and willing to comply with the protocol requirements
  • Able to understand and sign the Informed Consent form

Exclusion Criteria:

  • Active Neovascular Glaucoma in the study eye.
  • Corneal conditions in the study eye that may inhibit normal incisional healing (e.g. Fuch's dystrophy) or impair visualization of the implant inside the anterior chamber
  • Anticipated need for ocular surgery within one year in the study eye.
  • Contact lens use in the study eye
  • Clinically significant inflammation or infection in the study eye within 60 days prior to the preoperative visit or any systemic infection
  • Other clinical conditions including poorly controlled diabetes, cancer requiring treatment, any drugs or comorbidities that may inhibit wound healing
  • Participation in any other clinical trial during participation in this trial
  • Life expectancy less than 1 year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03469297

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Contact: Roy Martin 763-670-5600

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United States, Minnesota
Minnesota Eye Consultants Recruiting
Bloomington, Minnesota, United States, 55431
Contact: Kimberly Baker         
Principal Investigator: Patrick J Riedel, MD         
United States, Ohio
iWorks Laser and Vision Center Recruiting
Dayton, Ohio, United States, 45405
Contact: Caitlin Phillips    937-912-4367      
Principal Investigator: Patrick L Spencer, DO         
United States, Texas
Glaucoma Associates of Texas Recruiting
Dallas, Texas, United States, 75231
Contact: Samantha Villa    214-360-0000 ext 123      
Principal Investigator: Davinder S Grover, MD         
Sponsors and Collaborators

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Responsible Party: MicroOptx Identifier: NCT03469297     History of Changes
Other Study ID Numbers: 4039
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases