INTACS KERATOCONUS PDF

As part of the HDE approval, Addition Technology, the manufacturer of Intacs, has implemented an extensive training program in which each surgeon will be required to participate. The humanitarian device regulations were first established in October Humanitarian Use Devices HUDs are medical devices specially designated by the FDA for use in the treatment of fewer than patients per year with rare medical conditions. It is up to the insurance company to determine the amount to be paid.

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Study record managers: refer to the Data Element Definitions if submitting registration or results information. The two tiny INTACS inserts are surgically placed into the periphery of the cornea through a tiny cut that is made on the cornea after numbing drops have been applied. A specially designed instrument creates a tunnel by separating the tissue layers in the outside periphery of the cornea, the INTACS inserts are placed into this tunnel where they remain.

One or two ophthalmic sutures will be placed to close the incision. A postoperative care information booklet will be given to the patients; patients will be followed by means of postoperative appointments for up to 12 months after the surgery. Pre-OR visit 1. Talk with your doctor and family members or friends about deciding to join a study.

To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Who have experienced a progressive deterioration in their vision, such thot they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles; Who are 21 years of age or older; Who have clear central corneas; Who have a corneal thickness of microns or greater at the proposed incision site; Who have corneal transplantation as the only remaining option to improve their functional vision.

Who have abnormally thin corneas or who have a corneal thickness of microns or less at the proposed incision site;. Patients with collagen vascular, autoimmune or immunodeficiency disease;. Presence of ocular conditions, such as recurrent corneal erosion syndrome or corneal dystrophy, that my predispose the patient to future complications;. Patients who are taking on or more of following medications: isotretinoin Accutane ; amiodarone HCL Cordarone.

Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms x. COVID is an emerging, rapidly evolving situation. Save this study.

Warning You have reached the maximum number of saved studies Intacs for Keratoconus The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Last Update Posted : April 21, See Contacts and Locations. Study Description. Detailed Description:. Post-OR 3 month 1. Post-OR 12 month 1. FDA Resources. Arms and Interventions. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Who have experienced a progressive deterioration in their vision, such thot they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles; Who are 21 years of age or older; Who have clear central corneas; Who have a corneal thickness of microns or greater at the proposed incision site; Who have corneal transplantation as the only remaining option to improve their functional vision.

Exclusion Criteria: Who have abnormally thin corneas or who have a corneal thickness of microns or less at the proposed incision site; Patients with collagen vascular, autoimmune or immunodeficiency disease; Pregnant or nursing patients; Presence of ocular conditions, such as recurrent corneal erosion syndrome or corneal dystrophy, that my predispose the patient to future complications; Patients who are taking on or more of following medications: isotretinoin Accutane ; amiodarone HCL Cordarone.

Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. Miller UTSouthwestern. Fuerte UTSouthwestern. Leach UTSouthwestern. More Information. Cornea Keratoconus Steep cornea. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Device: Intacs. Not Applicable. Study Type :. Estimated Enrollment :. Study Start Date :. Estimated Primary Completion Date :. Estimated Study Completion Date :. Keratoconus Corneal Diseases Eye Diseases.

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INTACS for KERATOCONUS

Toggle navigation. Find a Job Post a Job. In some conditions, when no cure is available, sometimes simply preventing further progression can be enough to help the patient. As with any corneal procedure, however, especially one involving the use of a device, a breakdown in technique can lead to intraoperative difficulties or postoperative complications. Planning the Procedure In patients with keratoconus, placing intracorneal ring segments shortens the arc length of the corneal curvature and creates an artificial limbus within the cornea.

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Stabilizing the Cornea with Intacs

Our advertisers are important supporters of this site, and content cannot be accessed if ad-blocking software is activated. Need help? Click here for instructions. All Rights Reserved Privacy Policy. C3-Riboflavin for the Treatment of Keratoconus.

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Intacs placement in contact lens-intolerant keratoconus patients now at 2-year follow-up

Boxer Wachler, MD. Intacs corneal inserts or implants are a minimally invasive surgical option used primarily for the treatment of keratoconus. Originally FDA -approved in for the surgical treatment of mild myopia The FDA in July granted Intacs a Humanitarian Device Exemption for use in the treatment of keratoconus largely because of Intacs' safety record and because only a few treatment options, such as corneal transplants , were available for keratoconus.

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Intacs corneal inserts or implants: A proven treatment for keratoconus

CANNES, France — Positive results obtained on an increasing number of cases indicate that Intacs micro-thin prescription inserts may be an effective method for treating keratoconus patients with contact lens intolerance, according to a report on 2-year results with this technique. Penetrating keratoplasty PK has a good rate of success regarding visual acuity but should always be delayed as long as possible, especially in young patients, Prof. Colin said. When the cornea has become opaque and irregular astigmatism has become severe, there is no option other than keratoplasty.

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