Dr. Holzman announces FDA study

posted Jul 14, 2012, 11:50 AM by Jen Weigel   [ updated Jul 23, 2012, 6:17 PM ]
From the desk of Dr. Andrew Holzman

"Dear Affiliate Doctor,

We are proud and pleased to announce that we (Dr Jonathan Solomon, Dr Jen Weigel and I) have officially been accepted as investigators in the upcoming FDA Phase III Corneal Cross-Linking (CXL) study protocol number ACOS-KXL-001.

The study is sponsored by the American-European Congress on Ophthalmic Surgery (ACOS) and will utilize Avedro's KXL System (UVA CXL Illumination Lamp) with VibeX (Riboflavin Ophthalmic Solution) for patients with documented Keratoconus.  Qualified patients will receive an epithelium off treatment followed by one of three different CXL treatments. We are excited that this study involves using higher power and SHORTER duration treatments than previously used before.  Treatments will be randomized to durations between 2 and 8 minutes, as opposed to 30 minutes required with other UVA sources and study protocols. Patients will be followed for a year with a schedule similar to PRK post-op.

All visits and procedures will be performed at the same convenient location where your current refractive surgery patients are seen now.  As a reminder, our physical address is 7930 Jones Branch Drive, Suite 250, McLean, VA 22102.  Our phone number is 703-556-9144 and our fax is 703-761-4960.  

We thank you in advance for your help as we conduct this very important scientific study of corneal cross-linking.  We are excited to be offering such an important service to your patients, and we are excited about the expedited treatment parameters, making the procedure much easier and faster than in the past.   Please feel free to contact us with any questions you may have.

NOTE:  All patients referred in by Affiliate Doctors will be seen as general keratoconus evaluations.  At the end of the evaluation, your patient will have a good understanding of all KCN treatment options, including but not limited to, observation, CXL, Intacts, and PKP.  Working with Drs. Holzman and Solomon, the best treatment plan suitable to your specific patient's needs will be determined.  As usual, you will be kept updated on your patient's progress.

Respectfully,

Andrew E. Holzman, MD, FACS

Jonathan Solomon, MD

Jen Weigel, OD, FAAO"

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