12-month results positive for laser presbyopia reversal

October 22, 2004

Laser presbyopia reversal (LAPR) is showing significant promise and patient satisfaction based on 12-month follow-up results from a U.S. clinical trial, said Sandra C. Belmont, MD, at the refractive surgery subspecialty day meeting.

New Orleans-Laser presbyopia reversal (LAPR) is showing significant promise and patient satisfaction based on 12-month follow-up results from a U.S. clinical trial, said Sandra C. Belmont, MD, at the refractive surgery subspecialty day meeting.

Dr. Belmont is a principal investigator in the two-center study that is being conducted at Weill Cornell Medical College, New York, and with Jon Siems, MD, at his private clinic in Las Vegas.

The procedure involves use of an erbium:YAG laser (OptiVision, SurgiLight) to create eight radial incisions in the sclera. The study enrolled 60 eyes of 30 patients with a mean age of 53 years (range 50-58). The eligibility criteria required patients to have accommodation (2.5 D, stable manifest refraction between -4.5 and +7.5 D, normal IOP, (0.75 D astigmatism, and no prior ophthalmic surgery.

Patients were able to read immediately after surgery, and at 12 months, the group demonstrated a statistically significant increase in near UCVA, with 90% achieving J3 or better. In addition, 100% of eyes had >1 D increased amplitude of accommodation with a mean increase of 2.4 D. One patient with a poor 12-month near vision outcome had resumed spectacle wear. Safety was favorable with no changes in IOP or corneal topography.

Other measurements showed the surgery resulted in an approximate 10-mm increase in circumferential diameter of the globe along with a statistically significant decrease in axial length and a statistically significant decrease in anterior chamber depth, which might reflect forward movement of the crystalline lens.

From the perspective of the surgeon, this procedure is easy to learn, although it takes about 45 minutes per eye, and so far, the patients are very happy, although it is important to make sure they do not return to wearing their glasses or they will lose the effect, Dr. Belmont said.

The trial is now being expanded to eight sites in the United States. LAPR is being performed in the Pacific Rim and recently received an approvability letter for the CE mark.