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Trial record 2 of 3 for:    microoptx | glaucoma
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Early Feasibility Study of the Brown Glaucoma Implant in Patients With Severe Visual Impairment or 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03469297
Recruitment Status : Active, not recruiting
First Posted : March 19, 2018
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
MicroOptx

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
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 : December 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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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.


Outcome Measures
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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 ]

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

Inclusion Criteria:

  • Age 22 years and older
  • Primary-open angle glaucoma
  • 20/400 or worse
  • Intraocular pressure in the study eye greater than or equal to 21 mmHg and less than or equal to 50 mmHg
  • 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.
  • Pigmentary or pseudoexfoliative glaucoma in 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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03469297


Locations
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United States, Minnesota
Minnesota Eye Consultants
Bloomington, Minnesota, United States, 55431
United States, Ohio
iWorks Laser and Vision Center
Dayton, Ohio, United States, 45405
United States, Texas
Glaucoma Associates of Texas
Dallas, Texas, United States, 75231
Sponsors and Collaborators
MicroOptx
More Information
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Responsible Party: MicroOptx
ClinicalTrials.gov Identifier: NCT03469297    
Other Study ID Numbers: 4039
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
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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Glaucoma
Ocular Hypertension
Eye Diseases