Intacs corneal inserts for adults with keratoconus

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with keratoconus whose vision has gotten worse. Glasses or contact lenses no longer give them enough everyday vision. A corneal transplant must be the only option left to improve their vision.

Age

The criteria say 21 years of age or older. The registry lists a minimum age of 18 Years.

Sex

All sexes can join.

Disease stage

Keratoconus with vision that keeps getting worse. The centre of the cornea (the clear front of the eye) must be clear. The cornea must be 450 microns thick or more where the cut will be made.

Earlier treatment

Contact lenses or glasses no longer give enough everyday vision.

Main reasons for not taking part

• Very thin cornea, 449 microns or less where the cut will be made
• Collagen vascular disease, autoimmune disease or a weak immune system
• Being pregnant or breastfeeding
• Eye problems that could lead to later complications, such as recurrent corneal erosion syndrome or corneal dystrophy
• Taking isotretinoin (Accutane) or amiodarone HCL (Cordarone)

The registry criteria, word for word

What the trial wants to find out

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.

The group in the trial

• Intacs DeviceOther group

  INTACS® prescription inserts are an ophthalmic medical device designed for the reduction or elimination of myopia and astigmatism in patients with keratoconus so that their functional vision may be restored and the need for a corneal transplant procedure can potentially be deferred.

  Treatment: Intacs