Clarification about availability of TUG in the US.
3
Entering edit mode
7 weeks ago
Jo Ann • 140
@jo_ann

Dr. Schwartz, Could you please clarify the availability and location of receiving TUG therapy. Are you associated with the Long Beach, CA, practice that does TUG or are you pursuing another route? I am confused since it was previously stated that TUG was being performed at the eye center in Long Beach, CA. Why does it still need the FDA approval and clinical trials if it is already being done in Long Beach. Are you doing something different but related to the Long Beach procedure? Can patients receive the TUG therapy at the Long Beach clinic at the present time? Please clarify. Thank you!

glaucoma tug:therapeutic_ultrasound • 289 views
ADD COMMENTlink
1
Entering edit mode
4 months ago
david 3.9k
@david_fe

I am confused since it was previously stated that TUG was being performed at the eye center in Long Beach, CA.

Dr. Donald Schwartz did not say that. He said he had done four small studies from 2009 to 2014 at the Long Beach Eye location with an IRB oversight. Since then TUG has been used from 2018 to present in Mumbai, India by Dr. Ramesh C. Shah.

Interview with Dr. Ramesh C. Shah regarding Therapeutic Ultrasound for Glaucoma | Ask FitEyes

Can patients receive the TUG therapy at the Long Beach clinic at the present time?

No. See answer to next question below.

Could you please clarify the availability and location of receiving TUG therapy.

Currently it is only available in Mumbai, India through Dr. Ramesh C. Shah. It is not available in Long Beach, CA right now, but Dr. Donald Schwartz is seeking to raise funding for a clinical trial which he hopes to conduct at the location in Long Beach, CA.

With luck, it will be available in Long Beach, CA, in the near future -- only in the context of a clinical trial. It will possibly be more widely available in approximately two years, depending on fund raising and regulatory approvals.

Dr. Schwartz may further clarify; the above is my understanding.

ADD COMMENTlink
2
Entering edit mode

The use of the TUG device in Long Beach was under an IRB for clinical studies. Such studies may be performed as NSR (Non significant risk) if the IRB has reviewed pre-clinical work and agrees that the device is NSR. The other pathway is with an IDE (Exemption from the FDA to do studies) so that the FDA has data to review in the certification process. All of the work in Long Beach was under strict IRB approved studies. There have been no recent USA studies. It is hoped that enough funds can be raised to allow independent studies beyond the Long Beach facility.

ADD REPLYlink

Login before adding your answer.

Traffic: 4 users visited in the last hour

Use of this site constitutes acceptance of our User Agreement and Privacy Policy.