Media Release
15 October 2002

As appeared in the "Ocular Surgery News AAO Issue"

Technology Update

New Solid-State Refractive Surgery Laser System Emerges

Irving J. Arons
Spectrum Consulting

Over the years, there have been several attempts to develop and market
solid-state lasers for use in refractive surgery. Some of the earlier
attempts in the late 1980s were the nanosecond and picosecond YAGs (or YLFs)
that operated in the near infrared (IR) or at green wavelengths. Phoenix
Laser Systems (Alfred Sklar) and Intelligent Surgical Lasers (Josef Bille)
attempted to take advantage of photodisruption (with the Phoenix YAG) and
fast pulsed near IR (ISL) to vaporize tissue, in performing intrastromal
ablation within the cornea without affecting the corneal surface. The
results, however, were not very good or reproducible, and after rabbit
tests, few human experiments were ever tried.

Later, in the early 1990s, other companies tried to develop solid-state
lasers that emulated the excimer in operating at deep UV wavelengths. Two of
these were the LaserHarmonic quintupled YAG (JT Lin) from LaserSight and the
LightBlade, which I believe was an argon-pumped Ti Sapphire system (Shui
Lai) from Novatec. Neither system made it to the market, as the LaserSight
system never got beyond the experimental stage, and the Novatec system,
after some human clinical trials, simply ran out of funding.

More recently, TELCO of Australia, renamed Q-Vis, has shown its version of a
quintupled YAG, first called Eye-Q, but now renamed the Q-Vis Quantum 213,
operating at 213 nm. The laser has entered into human clinical trials, and
even began the long path toward U.S. FDA approval. These trials were begun
in the United States in July 2000. Late in 2001, the company learned that
some of the test results with its earlier model of the Quantum caused
significant undercorrections and the FDA testing was halted until
corrections in both engineering and its algorithms could be changed. At this
year's ASCRS meeting, the company said that the engineering corrections had
been made and that clinical trials were recommencing in Australia and
possibly Canada. No information about re-starting clinicals in the U.S. was
supplied.

Intralase (Ronald Kurtz), based on the earlier concepts from ISL, but using
femtosecond pulses rather than picosecond, is attempting to revitalize the
concept of intrastromal ablation. Only time will tell if this company is any
more successful than was ISL (or Phoenix).

And now, another Australian company, CustomVis, founded by Dr. Paul van
Saarloos, who was a co-founder of Q-Vis, and the inventor of its Quantum
solid-state laser (and also the Atlas corneal topography system sold by the
Humphrey division of Carl Zeiss Meditec), has come forward with its own
version of a solid-state system, the CustomVis Custom Corneal Reshaping
System, specifically designed for customized ablation. With both public
(Australian Government grants) and private financial backing, Dr. van
Saarloos hopes to bring a new solid-state approach to solve the custom
ablation puzzle. He has combined a new solid-state, diode-pumped, quintupled
YAG laser, operating at 213 nm with solid-state scanning and eyetracking to
deliver "better" custom outcomes for patients.

The new CustomVis Custom Corneal Reshaping System is composed of the Pulzar
small spot (0.6 mm), fast pulse (300 Khz), solid-state laser, combined with
an analog-based EX1 5 Khz gaze tracker, that locks onto the limbus and
monitors both eye movement and gaze direction with a closed-loop 1 Khz
response time. The diagnostic system utilizes an Orbscan topography device
for measuring surface abnormalities, and will, in the future, possibly use
the Tracey VFA (visual function analyzer) wavefront diagnostic for higher
order aberrations, along with a LASEK surgery approach to minimize flap
aberrations. (Presentations on this new approach to custom ablation surgery
will be given at this Fall's ISRS meeting, preceding the AAO, in Orlando.)

By proper registration of the wavefront and topography data, along with
minimizing the problems of centration and cyclorotation and intraoperative
eye and gaze tracking, along with utilizing LASEK to avoid flap problems,
the company hopes to minimize all potential problems and deliver superior
results.

Early patient trials with the system were conducted at the Laser Sight
centers of Australia in mid-September, and the first results will be
presented at the upcoming ISRS meeting. If the results with this integrated
system prove to be as good as anticipated, perhaps we will have found a
solid-state solution to the custom surgery puzzle.