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Trial record 1 of 1 for:    Beacon | Glaucoma | United States
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Study of the Beacon Aqueous Microshunt in Patients With Refractroy Glaucoma (Beacon)

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.
 
ClinicalTrials.gov Identifier: NCT04072016
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
MicroOptx

Brief Summary:
This is a prospective, multicenter, single-arm clinical study to evaluate the safety and effectiveness of Beacon Aqueous Microshunt in patients with refractory glaucoma.

Condition or disease Intervention/treatment Phase
Glaucoma Device: Beacon Aqueous Microshunt Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Beacon Study: A Prospective, Multicenter Study to Evaluate the Safety and Effectiveness of Beacon Aqueous Microshunt for Refractory Glaucoma
Actual Study Start Date : April 29, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Beacon Aqueous Microshunt Device: Beacon Aqueous Microshunt
The Beacon Aqueous Microshunt (BAM) is an implantable device intended to reduce intraocular pressure (IOP) in patients with refractory glaucoma by shunting aqueous humor from the anterior chamber to the surface of the eye.




Primary Outcome Measures :
  1. Effectiveness [ Time Frame: 12 Months ]
    20% mean diurnal IOP reduction from baseline, on the same number or fewer topical IOP-lowering medications

  2. Safety [ Time Frame: 12 Months ]
    Rate of occurrence of serious procedure-related and/or device-related adverse events.


Secondary Outcome Measures :
  1. Responder rate defined as achieving at least 20% mean diurnal IOP reduction from baseline [ Time Frame: 12 Months ]
  2. Mean Change from baseline in IOP [ Time Frame: 12 Months ]
  3. Schirmer tear test - mean change from baseline [ Time Frame: 12 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 to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Refractory glaucoma: Prior failure of filtering/cilioablative procedure and/or uncontrolled IOP on maximum-tolerated medication (i.e. >=4 classes of topical lowering medications, or fewer in the case of tolerability or efficacy issues).
  2. Primary open-angle, traumatic or neovascular glaucoma.
  3. Medicated DIOP ≥20 mmHg and ≤45 mmHg on maximum-tolerated medical therapy.
  4. Best-corrected baseline visual acuity of light perception or better in study eye.
  5. Participant has the understanding, ability, and willingness to fully comply with study procedures and postoperative care instructions.
  6. Participant understands and signs the informed consent.

Exclusion Criteria:

  1. No light perception vision.
  2. Pigmentary glaucoma in study eye.
  3. Pseudoexfoliation syndrome in study eye.
  4. Need for glaucoma surgery combined with other ocular procedures in the study eye at the time of implant (e.g. cataract surgery, penetrating keratoplasty, or retinal surgery).
  5. Unwilling to discontinue contact lens use in the study eye after surgery.
  6. Any condition that prevents the device implantation in the superior region of the study eye.
  7. Life expectancy <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 ClinicalTrials.gov identifier (NCT number): NCT04072016


Contacts
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Contact: Roy Martin 763-670-5600 rmartin@microoptx.com

Locations
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United States, Colorado
Icon Eye Care Recruiting
Grand Junction, Colorado, United States, 81501
Contact: Chris Bosch    970-205-9555      
Principal Investigator: James Fox, MD         
United States, Minnesota
Minnesota Eye Consultants Recruiting
Bloomington, Minnesota, United States, 55431
Contact: Kim Baker    952-567-6198      
Principal Investigator: Patrick J Riedel, MD         
United States, Ohio
iWorks Laser and Vision Center Recruiting
Dayton, Ohio, United States, 45405
Contact: Debra Jenkins    937-226-7870      
Principal Investigator: Patrick L Spencer, DO         
Sponsors and Collaborators
MicroOptx
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Responsible Party: MicroOptx
ClinicalTrials.gov Identifier: NCT04072016    
Other Study ID Numbers: 4046
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020

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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