Study of the Beacon Aqueous Microshunt in Patients With Refractory Glaucoma

Sponsor
MicroOptx (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04072016
Collaborator
(none)
90
Enrollment
6
Locations
1
Arm
79.1
Anticipated Duration (Months)
15
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Device: Beacon Aqueous Microshunt
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 29, 2020
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Effectiveness [12 Months]

    20% mean diurnal IOP reduction from baseline, on the same number or fewer topical IOP-lowering medications

  2. Safety [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 [12 Months]

  2. Mean Change from baseline in IOP [12 Months]

  3. Schirmer tear test - mean change from baseline [12 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 or traumatic 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Icon Eye CareGrand JunctionColoradoUnited States81501
2Minnesota Eye ConsultantsBloomingtonMinnesotaUnited States55431
3iWorks Laser and Vision CenterDaytonOhioUnited States45405
4Prism Eye InstituteOakvilleOntarioCanadaL6H0J8
5Institut de l'oeil des LaurentidesBoisbriandQubecCanadaJ7H 0E8
6Cliniques d' ophtalmologie BellevueMontréalQubecCanadaH1V1G5

Sponsors and Collaborators

  • MicroOptx

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MicroOptx
ClinicalTrials.gov Identifier:
NCT04072016
Other Study ID Numbers:
  • 4046
First Posted:
Aug 28, 2019
Last Update Posted:
Sep 23, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 23, 2021