You are of course right, Sajeev that C3R is not covered by FDA approval, but it ican be available in the United States under IRB supervision. Nonetheless, many practitioners in the United States, and some even in Europe (as well as many if not most ethics committees in the UK) still have their reservations about this treatment for Keratoconus.
Keratoconus Centre again:
This treatment claims to reverse keratoconus and stop its progression. Laboratory evidence performed to date by European investigators indicating that the collagen strength of the cornea is increased is quite good. The clinical evidence that it actually stops progression and reverses the disease is questionable at best. Clinical studies to date fail to convince me that there is any evidence that it retards the progression of the disease.
Long term longitudinal studies are required in which patients with the disease are followed over a long period of time compared to another group that has actively progressive disease to prove that this works. There is also currently lack of standardization as to how the treatment should be performed. My major concern is that if not correctly performed this procedure could result in long term damage to the retina resulting in irreversible visual loss.
We would run into serious dangers if the precautionary principle was not applied to the development of new and experimental therapies.
Andrew