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



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:22 - Any
Updated:8/17/2018
Start Date:May 1, 2018
End Date:May 2020
Contact:Roy Martin
Email:rmartin@microoptx.com
Phone:763-670-5600

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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.


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
We found this trial at
3
sites
Bloomington, Minnesota 55431
Principal Investigator: Patrick J Riedel, MD
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Bloomington, MN
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Dallas, Texas 75231
Principal Investigator: Davinder S Grover, MD
Phone: 214-360-0000
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Dallas, TX
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Dayton, Ohio 45405
Principal Investigator: Patrick L Spencer, DO
Phone: 937-912-4367
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Dayton, OH
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