Keratoconus treatment and FDA approvals


We have been receiving a lot of questions from patients via social media and telephone calls. People out there are confused regarding the safety and efficacy of the various advertised treatment methods for keratoconus.  A quick recap of the currently available interventions to help people suffering from keratoconus eye disease. We have Intacs, Cornea cross linking, DALK and Corneal transplant. Talk and corneal transplant are surgical techniques and and are not in purview of FDA. Lets confine our discussion today than to Intacs and cross linking of cornea for keratoconus eye disease.

Intacs for Keratoconus are FDA approved

Yes Intacs are the only intracorneal ring implants approved by FDA. Others like Ferras rings are not approved and cannot be sold in USA. DrKhanna is one of the participants an Institutional Review Board monitoring by Integrview.  This ongoing oversight ensures the results are safe.

Is Corneal Cross linking FDA approved?

There are three types of Corneal cross linking available in USA today.

  1. FDA approved : There is one and only one FDA approved – KXL device and riboflavin called Photrexa manufactured by Avedro. This means that Avedro did a clinical study to demonstrate the safety and efficacy of their  formulation with their unique device. Data was submitted to FDA. Federal Drug and Administration studied the repots. They asked questions and requested more data. Once this was reviewed  FDA approved the Avedro method.
  2. Clinical studies : There are clinical studies being performed by different groups like the AECOS and CXL study groups. Fda has not given the green light on them.
  3. God Given: These are devices which doctors cannot explain how they arrived in their  offices or surgery rooms. The data from these unexplained devices is not being submitted to FDA nor even peer review. No one knows what drugs are being used.

Which one should you use?

FDA ensures the safety of our eyes. They review the statistical data to keep us safe. Therefore when comparing different treatments it is easier for us to know which is safer.

Since there is only one FDA approved cross linking choose AVEDRO cornea cross linking.

Learn more about treatment modalities for keratoconus.

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