I am amazed when doctors claim that they have invented a procedure even though it has existed for years before. For example a surgeon claiming they invented cornea cross linking even though it was being performed in Europe for many years.
What gets me peeved is that some doctors use unproven technology and convince patients its the best. Snake oil sellers are an amusement till patients are harmed. So I decided to list some truths about keratoconous eye disease and cornea collagen cross linking.
The 10 Golden Truths about Cornea Cross Linking By Rajesh Khanna, MD a Keratoconus specialist.
- Keratoconus is a sight threatening disease. It involves the thinning and bulging of the cornea.
- Recent data suggests it may be more prevalent than 1 in 2000 people
- Cornea Collagen Cross Linking (CXL) is a proven and effective way to halt the progression of progressive keratoconus eye disease.
- CXL may be used to stabilize post lasik ectasia.
- Epithelium off Cornea cross linking is more effective than epi on cross linking.
- Conventional cornea cross linking – 3 mw for 30 minutes is the gold standard.
- Conventional cross linking is more effective than accelerated cross linking (18 mw or 30 mw). No other power setting is better.
- No studies have shown epi on cross linking to be more effective than conventional epi off cross linking.
- FDA has only approved Avedro KXL system/Photrexa for treatment of progressive keratoconus. No other system nor riboflavin compound has passed that litmus test.
- Avedro KXL/ Photrexa which treats at 3mw is currently safer and more effective than other currently available epi on choices in Los Angeles
I would invite comments by optometrists, ophthalmologists and peers especially keratoeonus experts.
Avedro KXL system in the hands of an experienced Keratoconus surgeon following FDA protocols would be safer than an unproven experimental epi on technology. We therefore offer Avedro cornea collagen cross linking with the FDA approved protocol.
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. This is 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. DALK and Corneal Transplant are surgical techniques and thus are not in the purview of the FDA. Let us confine our discussion today than to Intacs and Cross Linking 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. Dr. Khanna is one of the participants in an Institutional Review Board monitoring by Integrview. This ongoing oversight ensures that the results are safe.
Is Corneal Cross linking FDA approved?
There are three types of Corneal cross linking available in the US today.
- 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 the FDA. Federal Drug and Administration studied the reports. They asked questions and requested more data. Once this was reviewed FDA approved the Avedro method.
- 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.
- 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 procedure, choose AVEDRO Cornea Cross Linking.
Learn more about treatment modalities for keratoconus.