EyeWorld report about LADARVision®

To read full article

Please click here to read the full article on the January 2005 edition of EyeWorld, on their website.

Excerpts from "Lasers or surgeons: What's really the cause of high retreatment rates?"

Dr Sam Omar's comments

Sam Omar, M.D., medical director, Advanced Vision Institute, Longwood, Fla., said after he did about 40 cases with LADARVision... he stopped using the machine due to both a high retreatment rate and poor outcomes....

In order to fix the problem, Dr. Omar said he modified his nomogram three times and worked with Alcon staff, but the problem remained unresolved.
“LADARVision at times would be spectacular,” Dr. Omar said. “Other times, the result would be a failure....”

Dr Roy Rubinfeld's comments

“While none of the multiple laser platforms I have used since 1996 is perfect, my experience with LADARVision was particularly troubling,” said Roy S. Rubinfeld, M.D., of Washington Eye Physicians & Surgeons, Chevy Chase, M.D. “I had several occasions where the thing would just stop working,” said Rubinfelf....

“I had one time where I had to put the flap back with a flashlight because the illumination light went off so I couldn’t figure out where the flap was,” Dr. Rubinfeld said.

Dr Peter Hersh's comments

[These comments are in the context of discussion of a study authored by Dr. Hersh and which indicated the LADARVision retreatment rates were approximately double those of the Summit Apex plus. Also note that a postscript to the article indicates Dr Hersh is a consultant to Alcon.]

While the retreatment rate associated with LADARVision was almost double that of the Summit Apex Plus in the study, Dr. Hersh concluded that “the difficulty of the initial procedures performed on the LADARVision laser, for example, higher degrees of astigmatism correction or mixed astigmatic corrections, compared with the Apex Plus laser, where more spherical myopic corrections were treated, may partially account for these findings.”

Furthermore, Dr. Hersh concluded that because the LADARVision was the newer machine in his practice, patient expectations could have been greater with the platform, causing more desire for enhancement. Later, during an e-mail exchange, Dr. Hersh said: “We did not at all concentrate on or design our methodology based on the difference between lasers. Thus, this is the wrong study from which to draw any conclusions regarding differences in retreatment rates between different systems.”

Dr Doyle Stulting's assertion, vs Alcon's assertion

Alcon receives primary and secondary procedure data from all LADARVision 4000 machines for billing purposes, but surgeons contend it is not something they can readily retrieve from Alcon.

“Alcon refused to supply their billing information showing retreatment rates on our LADARVision laser after I requested that they do so,” said R. Doyle Stulting, M.D., Ph.D., professor of ophthalmology, Emory University, Atlanta.

Officials at Alcon said the information is readily available to individual surgeons.

data presented in court

According to data presented under oath in a deposition, 27 U.S. surgical sites enhanced 20% or more primary LADARVision treatments from 2000 to 2002. That percentage is based on the ratio of all retreatments to all primary treatments recorded during that time frame. In 2002 alone, the data indicate that 55 sites had enhancement rates of 20% or greater, although sources familiar with the data noted that the enhancement rates could be somewhat off (either larger or smaller) depending upon whether some retreatments occurred at sites other than the original, occurred after primary treatments in previous years, or for other reasons.