Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2002-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
2 HEMA Hydrophilic Acrylic Intraocular Lens
2 HEMA Hydrophilic Acrylic Intraocular Lens implanted into the posterior capsule following cataract surgery for patient life duration.
Interventions
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2 HEMA Hydrophilic Acrylic Intraocular Lens
2 HEMA Hydrophilic Acrylic Intraocular Lens implanted into the posterior capsule following cataract surgery for patient life duration.
Eligibility Criteria
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Inclusion Criteria
* The patient is willing and able to complete all required postoperative visits.
* The patient is willing to sign a statement of informed consent.
Exclusion Criteria
* The patient has had prior intraocular surgery in the operative eye.
* The patient has systemic diseases with ocular manifestations (e.g. diabetes, complications of immune deficiency syndrome), which may contribute to postoperative confounding of data interpretation.
* The patient's worst seeing eye is 20/70 or worse.
* The patient has multiple surgical procedures at the time of implant.
* The patient has chronic use of steroids, immunosuppressive and/or antineoplastic agents.
* The patient has acute infection, inflammation of the eye.
* Iris atrophy
* Proliferative diabetic retinopathy.
* Chronic, medically uncontrolled glaucoma
* Chronic uveitis, iritis, iridocyclitis or rubeosis of the lids
* Rubella, traumatic or congenital/developmental cataract.
* Severe retinal pathology (e.g. retinal tear, detachment, etc).
* Capsular rupture
* Vitreous loss
* Hyphema
* Zonular disinsertion
* Surgical Complications- In the event of a complication during surgery, the surgeon should decide whether the stability of the hydrophilic acrylic lens would be compromised by the complication, e.g. in the event of zonular damage of major capsule rupture. If the lens stability would be compromised, the hydrophilic acrylic lens should not be implanted and the surgeon should make arrangements to implant an alternative lens.
18 Years
ALL
No
Sponsors
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EyeKon Medical, Inc.
INDUSTRY
Responsible Party
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EyeKon Medical, Inc.
Principal Investigators
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James Garvey, M.D.
Role: STUDY_DIRECTOR
David C Brown, M.D.
Role: PRINCIPAL_INVESTIGATOR
Eye Centers of Florida
Michael S Korenfeld, M.D.
Role: PRINCIPAL_INVESTIGATOR
Comprehensive Eye Care LTD
James E Croley, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cataract and Refractive Institute of Florida
Larry Perich, D.O.
Role: PRINCIPAL_INVESTIGATOR
The Perch Eye Center
Thomas L Croley, M.D.
Role: PRINCIPAL_INVESTIGATOR
Central Florida Eye Institute
Farrell C Tyson, M.D
Role: PRINCIPAL_INVESTIGATOR
Cape Coral Eye Center
James P Gills, M.D.
Role: PRINCIPAL_INVESTIGATOR
St. Lukes Cataract and Laser Center
Robert Weinstock, M.D
Role: PRINCIPAL_INVESTIGATOR
The Eye Institute of West Florida
Locations
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Cape Coral Eye Center
Cape Coral, Florida, United States
Cataract and Refractive Institute of Florida
Cape Coral, Florida, United States
Eye Centers of Florida
Fort Myers, Florida, United States
Riverside Park Surgicenter
Jacksonville, Florida, United States
The Eye Institute of West Florida
Largo, Florida, United States
The Perich Eye Center
New Port Richey, Florida, United States
Central Florida Eye Institute
Ocala, Florida, United States
St. Lukes Cataract and Laser Center
Tarpon Springs, Florida, United States
Comprehensive Eye Care Ltd.
Washington, Missouri, United States
Countries
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Other Identifiers
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EyeKon SC25-FOLD
Identifier Type: -
Identifier Source: org_study_id
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