OUR
FORMAL FLOATER STUDY
|
(In experienced hands, laser treatment of eye floaters is perhaps the safest procedure of intraocular eye surgery. The U. S. Food and Drug Administration when approving YAG lasers for this procedure, classified this as a non-significant risk procedure.)
In June 2002 we began our formal
research study to determine the effectiveness and safety of laser
treatment of eye floaters.
The study had been formally reviewed to ensure that the study was well
designed, all possible subject safeguards were built in, any
complications would be promptly reported, and subjects would be
informed about all aspects of the study including the risks and
benefits.
The preparation
for this study was extensive. The U. S.
Food and Drug Administration had not previously approved the use of a YAG laser
to treat vitreous opacities. Therefore, our
seven inch thick application, along with our 61 patient pilot study, was submitted
to them to obtain an Investigational Device Exemption for use of a YAG laser in our study. They ruled that our
study was a non-significant risk device study and further ruled that a
conventional YAG laser could be used in our study without an Investigational
Device Exemption. The study was then
organized under FDA guidelines. Another
extensive document for the study was submitted to the Inova Fairfax Hospital
Institutional Review Board of Falls Church, Virginia. This hospital is consistently ranked in the
top 100 hospitals in America. The Board voted to approve and to monitor our
study. An informed consent document approved by the Institutional Review Board was obtained from each patient. All data and progress of the study was sent
to that Board and also to the FDA. These important
steps make the study eligible for publication in peer review journals.
One year follow up of the last patient in our study was obtained in March 2005.
The results
of the Study were:
1) the laser procedure was successful (using our five criteria
of success) in 92 per cent of patients,
2) when the procedure was not successful, no patient was
made worse, there was no harm done, and there was no evidence
that a procedure had been done, and
3) there were no significant complications.
(more details pages 64-70 Our Book) |
