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 |
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.
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
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Dallas, Texas 75231
Principal Investigator: Davinder S Grover, MD
Phone: 214-360-0000
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Dayton, Ohio 45405
Principal Investigator: Patrick L Spencer, DO
Phone: 937-912-4367
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