A Prospective, Multicenter, Open-label, Safety and Preliminary Efficacy Study of the Surgical Implantation of OPKO's Glaucoma Drainage Device (AquashuntTM) in Patients With Refractory Chronic Forms of Open Angle Glaucoma (OAG)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-05-31

Brief Summary

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A prospective, multicenter, open-label, safety and preliminary efficacy study of the surgical implantation of OPKO's glaucoma drainage device (AquashuntTM) in patients with refractory chronic forms of open angle glaucoma (OAG). The primary objective of this study is to evaluate the surgical implantation, safety and preliminary efficacy of the AquashuntTM after implantation in patients with refractory chronic forms of OAG

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Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aquashunt

Open label, all subjects receive device.

Group Type OTHER

Aquashunt

Intervention Type DEVICE

A shunt which is implanted into the suprachoroidal space.

Interventions

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Aquashunt

A shunt which is implanted into the suprachoroidal space.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Patients of either sex will be eligible for the study if all of the following criteria are met:

1. Patients must be aged 18 years or more.
2. Patients must have a diagnosis of chronic forms of open angle glaucoma in the study eye, which is uncontrolled on maximum tolerated medical treatment with ocular hypotensive medications and has failed glaucoma surgery or is not considered a reasonable candidate for traditional surgery.
3. The patient's documented IOP must be considered by the treating physician to be too high for their glaucoma status.
4. Patients must have BCVA of between 20/400 and Light Perception, or no light perception with pain, in the study eye.
5. Patients must have a BCVA in the fellow eye, which is better than that of the study eye.
6. Patients must be mentally competent and willing to provide informed consent.
7. Patients must be willing to return for all study visits and assessments for at least 3 years after surgery.

Exclusion Criteria

Patients will not be eligible for the study if any of the following criteria are present:

1. Patients with a diagnosis of glaucoma other than open angle glaucoma including active uveitic, active neovascular or recent traumatic glaucoma.
2. Patients with clinically significant corneal disease including corneal dystrophy.
3. Patients with iridocorneal endothelial syndrome.
4. Any previous ocular surgery other than trabeculectomy, trabeculoplasty or cataract surgery and any surgery (including laser) within previous 3 months.
5. Patients with an Anterior Chamber configuration that puts the patient at high risk for the development of angle closure glaucoma.
6. Patients with any recent (within previous 30 days), or current, ocular/periocular inflammation or infection.
7. Patients with a history of extensive keloid formation.
8. Patients who will need ancillary procedures in the study eye at the time of implantation or during the initial one year study period.
9. Patients who have any known intolerance or hypersensitivity to topical anesthetics, mydriatics or components of the device.
10. Patients who are unable to interrupt their anti-coagulant, anti-platelet or NSAID (including aspirin) therapy for at least 3 weeks prior to surgery.
11. Patients who have within the previous 3 months, are currently, or intend to participate in a study with any investigational agent (drug or device).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No