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GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma

2014-08-27 03:16:32 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and efficacy of the GTS400 trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.

Description

Glaucoma is a collection of disorders characterized by progressive loss of visual field due to optic nerve damage. It is a leading cause of blindness in the United States, affecting 1-2% of individuals aged 60 and over. Management of glaucoma requires chronic, life-long treatment with a spectrum of therapeutic options including medications, laser treatment and surgical implants. The common goal among the various therapies is to lower intraocular pressure to target levels in order to prevent loss of visual fields from excessive pressure on the optic nerve.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Glaucoma

Intervention

iStent Inject (GTS400), Cataract Surgery

Location

Boozman-Hof Regional Eye Clinic
Rogers
Arkansas
United States
72756

Status

Recruiting

Source

Glaukos Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:32-0400

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A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.

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Medical and Biotech [MESH] Definitions

Loss of CORNEAL ENDOTHELIUM usually following intraocular surgery (e.g., cataract surgery) or due to FUCHS' ENDOTHELIAL DYSTROPHY; ANGLE-CLOSURE GLAUCOMA; IRITIS; or aging.

The making of a continuous circular tear in the anterior capsule during cataract surgery in order to allow expression or phacoemulsification of the nucleus of the lens. (Dorland, 28th ed)

Partial or complete opacity on or in the lens or capsule of one or both eyes, impairing vision or causing blindness. The many kinds of cataract are classified by their morphology (size, shape, location) or etiology (cause and time of occurrence). (Dorland, 27th ed)

Separation of the inner layers of the retina (neural retina) from the pigment epithelium. Retinal detachment occurs more commonly in men than in women, in eyes with degenerative myopia, in aging and in aphakia. It may occur after an uncomplicated cataract extraction, but it is seen more often if vitreous humor has been lost during surgery. (Dorland, 27th ed; Newell, Ophthalmology: Principles and Concepts, 7th ed, p310-12).

A procedure for removal of the crystalline lens in cataract surgery in which an anterior capsulectomy is performed by means of a needle inserted through a small incision at the temporal limbus, allowing the lens contents to fall through the dilated pupil into the anterior chamber where they are broken up by the use of ultrasound and aspirated out of the eye through the incision. The small incision allows the surgeon to use very few or even no stitches to close the tiny wound. There is usually no need for hospitalization and patients may resume most activities within days. (Cline, et al., Dictionary of Visual Science, 4th ed & In Focus 1993;1(1):1)

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