Accommodative laser procedure en route to clinical trials
The LaserACE procedure to restore accommodation is entering a Canadian trial in December.
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 clinical efforts.
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 claims.
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 Diego.
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; email: firstname.lastname@example.org.
- Disclosure: Dr. Hipsley is the founder of Ace Vision Group and the inventor of the LaserACE procedure.