09/25/2008 HELP Stop Keratoconus disease

I am on a mission to stop Keratoconus disease. This New procedure called CXL needs to be FDA approved so NO other person has to endure the pain of Advanced keratoconus, hydrops or Cornea Transplant(due to KC) ever again. While I am waiting on the approval for the compassionate exception from the Emory IRB, I decided to go forward with this mission. Please Email me if you are interested in helping to stop Keratoconus disease.

eye healing

Nick's hydrop in his right eye has healed ( he no longer needs to wear the arm casts) but he is unable to see out of it because of the huge scarring. Nick will have a cornea transplant in his right eye and in the left eye have the CXL procdure. But this is the deal--Nick is unable to have his cornea thickness measured to know if the CXL can even be done. Dr. Stulting will still file for a compassionate exception with the Emory IRB & FDA. Keep in your prayers that Nick's cornea will be thick enough to have the CXL procedure. In 3 weeks we will get an update to where the IRB is. Within 4-12 weeks hopefully Nick will have all his eye procedures. I will post updates

September 18,2008

I am really getting nervous about this whole thing. If you have read Nick's story and all the updates you should be caught up by now. Because Nicholas is Nicholas, the doctors have been unable to get his cornea thickness measured so therefore it is still questionable to whether or not he is a Candidate. With this CXL procedure, doctors do not sedate the patient so therefore, No doctor wanted to deal with Nicholas- NOT even the doctor in Europe. We are very grateful that Dr. Stulting and the Emory team want to be involved in our situation. Nicholas got the worst thing that ever happens to a cornea patient (Hydops). It was a crisis situation but now it is over and has left a scare on his right cornea. As of today the plan is: When the Institutional Review Board (IRB)of Emory approves the compassionate waiver then it is sent to the FDA. On July15 I wrote Senator Isakson to get in touch with the FDA about this situation and on July 19, David Bands from Washington FDA called me and said that it was not going to be a problem to get it through. Today, I got an update letter that you can read below. The plan is to put Nicholas under sedation and do a cornea transplant in the right eye and the CXL in the left eye. (It is said that if we do not get the cornea transplant in his right eye it will keep getting worse.) thanks for caring Nick's mom Janis: Our Amendment to get compassionate use is under "expedited review" as of 9/16/2008. I truly cannot speak to when we should have approval for that, as it's the IRB that moves this along, but it does appear that our original estimate of having IRB approval by late October still appears to be in the cards. It still remains possible that they would have questions before granting approval, and we will move quickly. BUT - Once that is approved, I am sure either myself or someone from the study will be in touch to schedule the next step. I remain happy to answer any questions you have, and I'll let you know if anything changes before our anticipated approval. Paul Larson Emory Eye Center

Sept 12, 2008

Nick's sore on his arm is almost healed. We are still waiting to hear from Dr. Stulting on where the Emory IBR is. A cornea transplant is a very scary thing but that could be Nicks only option for his right hydrops eye and the long awaited CXL procedure.

Nick's Story

Nicholas Richards, who has Down Syndrome, is 25 years old and live in Marietta, Ga. In 2007, Nick was diagnosed with advanced Keratoconus. On July 14, 2008, Nick's right eye developed hydrops . For weeks we struggled to keep Nick from rubbing his painful hydrops eye. The more he rubbed the more painful it became. Nick didn't understand the damage he was doing to his eye. All he knew was that it hurt and he needed to rub it. We tryed every thing we could think of from place his arms in cardboard tubs to splitting his arms with soccer shin guards. Then on August 3, we saw a lady in Home Depot with her arm in a half cast. That was it! our blessing had been answered. We needed her other half cast so Nick could not bend his arm to touch his eye. On Monday, August 4, Nick's dad called The Center For Orthopaedics & Sports Medicine office, in hopes they would hear our desperation cry. When, Master Caster, Paula Owens said, " come in Tuesday, at 7:45am", we knew that God heard our prayer. So on August 5, we minimized the further damage that Nick might have caused by having the half casts made for his arms. This video of Nick having his casts made was a Thank you Orthopaedic Doctor, Dr. Craig Weil and Mast Caster, Paula Owens for responding so quickly to our cry for help with their generous caring heart and technical knowledge. Normal care for a person whose eye has suffered a hydrop is a cornea transplant. We will update you, if this surgery is a possiblity. While Nick's left eye has not yet suffered a hydrop, the keratoconus(KC) disease is till progressing and thinning his cornea. A new, less invasive procedure called Corneal Cross-Linking(CXL) shows promise for treatment for keratoconus. It strengthens the cornea and halts the disease. The CXL is approved outside the US but only in clinical trials in the US. Because Nick's keratoconus is in the advanced stages and doctors have been unable to measure the thickness of his corneas, this CXL procedure for Nick will be determined in the near future. Dr. Doyle Stulting, at the Emory Eye Center in Atlanta, Georgia, is the lead investigator for the CXL clinical trial. In January,2008, Emory Eye Center was the first U.S. site to conduct keratoconus trials. Dr. Stulting and his medical team are pursuing a compassionate exemption, because Nick does not qualify for the trial, so he could possibly receive this treatment. This exemption statues will require time and resources. Keep Nick in your prayers and if you can donate to our local disability organization (Right In The Community) in dedication of Nicholas Richards. We will post any updates.

Hydrops

A rare extremely painful complication of Keratoconus. It's a split within the internal layers of the cornea. Fluid enters the cornea within the eye. The cornea becomes acutely swollen & opaque. As the split heals over weeks or months, scarring occures. A corneal transplant could be the only treatment for improved vision. Nick's eye looked worse than the above hydrop eye because he was rubbing it.

Advanced keratoconus

Keratoconus is a progressive eye condition causing the cornea to weaken, thin & bulge. This condition may cause reduced vision, nearsightedness, and astigatism. Up until now, the tratitional treatment for improved vision was a corneal transplant.

sept 1,2008 update

Nicholas had a good weekend but is still saying that his right eye hurts. He is not wearing his casts at this time because he is not touching his right eye. Because Nick would twist his cast on his right arm, he developed an infection on his arm. It should clear up soon. Even though his birthday was Aug. 25, we are celebrating his 26th birthday on Sept.3.