Intacs Prescription Inserts for Keratoconus Patients

Recruiting now · Not applicable

Conditions studied: Keratoconus

In brief

The US food and Drug Administration (FDA) originally approved INTACS prescription inserts in April 1999 for the correction of low levels of nearsightedness (-1.00 to -3.00 diopters). Additional clinical data have shown that INTACS are safe for the treatment of keratoconus, in July 2004, FDA approved INTACS inserts for the treatment of keratoconus as a Humanitarian Use Device (FDA approval letter attached). The statute and the implementing regulation of FDA (21 CFR 814.124 (aj) require IRB review and approval before a HUD is used.INTACS prescription inserts are composed of two clear segments, each having an arc length of 150°, they are manufactured form a biomedical material called polymethylmethacrylate (PMMA) and are available in three thicknesses. Two INTACS inserts ranging from 0.250mm to 0.350mm may be implanted depending on the orientation of the cone and the amount of myopia and astigmatism to be reduced.

Key facts

Study ID

NCT02138669

Run by

University of Texas Southwestern Medical Center

People needed

25

Starts

2011-01-01

Expected to finish

2030-07-31

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 450 microns or greater at the proposed incision site; Who have corneal transplantation as the only remaining option to improve their functional vision.

You may not qualify if…

• Who have abnormally thin corneas or who have a corneal thickness of 449 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).

Where it is running

• UTSW Medical Center at Dallas — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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