The core principles of the LaserACE procedure for accommodation were
conceived in 2003 when Ann Marie Hipsley, DPT, PhD, postulated her VisioDynamic
Theory, which suggests that excisions in critical zones of the sclera can
restore some of the natural biomechanics of the accommodative system.
A protocol is in preparation for submission to Health Canada to initiate
clinical trial in Canada in December. This trial is being conducted as a first
step to gathering the necessary data to initiate discussions with the U.S. Food
and Drug Administration regarding the requirements for approval and potential
commercialization in the U.S.
We are extremely excited about our upcoming Canadian trial,
Dr. Hipsley, founder of Ace Vision Group and inventor of the LaserACE
procedure, said in an interview with Ocular Surgery News. We
raised the capital for this internally and with some new shareholders. We have
early previous data indicating the technique is effective, but the bar for
proof of accommodative effect has been raised in recent years. Our Canadian
trial includes a control group, incorporates objective measures of
accommodation and includes elements of the new ANSI standard being developed
for accommodating and pseudoaccommodating IOLs. If the results of this study
corroborate earlier findings, then we expect that a private or venture
capitalist funding partner would be very interested in supporting our FDA
Dr. Hipsley is vigilant against anything that could disrupt
LaserACEs path to full commercialization.
We dont want any off-label use because while we do have a
510(k) for the laser used, we have no specific claims, she said. We
dont want to run the necessary trials to obtain FDA approval with
How it works
LaserACE is one of the first procedures to use a laser to restore
natural accommodation. The VisioLite Er:YAG ophthalmic laser system is a
reliable solid-state laser, and it was the first Er:YAG laser to be approved
for ablation of eye tissue, Dr. Hipsley said.
The VisioDynamic Theory is based on the presumption that the loss of
accommodation is correlated with increased rigidity of the sclera and
compression over the ciliary muscle. To counteract this rigidity and restore
the eyes ability to naturally accommodate, a diamond shape of nine
full-thickness scleral ablations is made using the VisioLite laser in four
oblique-oriented quadrants of the anterior part of the scleral wall to restore
flexibility to the sclera. This also makes the procedure unique because it is
not on the visual axis, which gives it an excellent safety profile, according
to Dr. Hipsley.
In an international study of LaserACE on 137 eyes, 1 D to 1.5 D of true
accommodation was restored; 18 months later, results appeared to be stable,
with less than 0.25 D change. The study also showed an average IOP decrease of
3.18 mm Hg, according to Dr. Hipsley, who said the results were presented at
the 2011 American Society of Cataract and Refractive Surgery meeting in San
Patients uncorrected vision improved at near, and
intermediate and distance vision was the same or better than
preoperatively, she said. Because the procedure is designed to
restore natural accommodation, there is no trade-off of distance vision for
near vision, or the introduction of visual disturbances such as may be
associated with multifocal or aspheric presbyopic solutions.
Uses of the procedure
If LaserACE results produce an increase in accommodation over 1.5
D, we believe that the procedure will be very attractive to the 100 million
existing presbyopic patients and the 4 million who join them each year,
Dr. Hipsley said. This would also make it an option for refractive surgeons who
would like to provide vision care to patients in all stages of their lives.
For instance, they may provide LASIK or PRK to patients in their
20s or 30s, LaserACE to treat presbyopia in the late 40s and 50s, then
refractive cataract surgery in the 60s and 70s, she said.
It is also a very adaptable technology.
Potential future applications of the laser to the eye include a
glaucoma treatment, a posterior globe ocular nerve and fiber treatment, and a
treatment for pterygia, Dr. Hipsley said. Essentially, anything
thats being performed by a knife or a blade in or outside the eye would
be an appropriate area to explore. by Daniel R. Morgan
- Ann Marie Hipsley, DPT, PhD, can be reached at Ace Vision Group, 2941
Kent Road, Cuyahoga Falls, OH 44224-3700; 330-475-5223; fax: 330-319-7889;
- Disclosure: Dr. Hipsley is the founder of Ace Vision Group and the
inventor of the LaserACE procedure.