Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma

NCT ID: NCT01401088

Last Updated: 2013-01-03

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction in patients with refractory glaucoma.

Detailed Description

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Aurolab Artificial Drainage Implant is a non resistant tube device based on Baerveldt implant. It reduces intra ocular pressure by draining aqueous from anterior chamber into sub-conjunctival space formed around base of the implant. Reduction of intraocular pressure prevents further damage to optic nerve and functional visual field loss in advanced refractory glaucoma.

Conditions

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Artificial drainage implant

Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction will be implanted in patients with refractory glaucoma.

Group Type EXPERIMENTAL

Artificial drainage implant

Intervention Type DEVICE

Artificial drainage implant is used for intra ocular pressure reduction in patient with refractory glaucoma

Interventions

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Artificial drainage implant

Artificial drainage implant is used for intra ocular pressure reduction in patient with refractory glaucoma

Intervention Type DEVICE

Other Intervention Names

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AADI

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Significant optic nerve damage and visual field loss due to glaucoma in eligible eyes
* Eligible eyes is considered at high risk of failure/complication following conventional filtering surgery
* Eyes with uncontrolled glaucoma with prior history of Filtering surgery/Uveitic/ Neovascular/Developmental glaucomas
* IOP≥18 mm of Hg with or without anti glaucoma medications
* If taking glaucoma medications, stable dose for 6 weeks

Exclusion Criteria

* Age\<18 years
* Eyes with uncontrolled glaucoma expected to have favorable post-operative outcome by conventional trabeculectomy
* Corneal abnormalities that would preclude accurate IOP readings
* Uncontrolled systemic diseases
* Endothelial cell count\<1800cells/mm
* Any other active ocular disease,(active uveitis, ocular infection)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aurolab

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Prashanth Ranganath, MBBS., MS.,

Role: PRINCIPAL_INVESTIGATOR

Aravind Eye Hospital, Madurai

Locations

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Aravind Eye Hospital

Madurai, Tamil Nadu, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Dr. Prashanth Ranganath, MBBS., MS.,

Role: CONTACT

+91 452 4356100 ext. 118

Mr.S.Karthi Kumar, M.Pahrmacy

Role: CONTACT

+91 452 4356100 ext. 229

Facility Contacts

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Mr. S.Karthi Kumar, M. Pharmacy

Role: primary

+91 452 3096100 ext. 229

Ms. Sophia, M.Sc

Role: backup

+91 452 4356100 ext. 364

Other Identifiers

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1PN1011049

Identifier Type: -

Identifier Source: org_study_id

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