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Up Front | Jan 2002

Surgical Reversal of Presbyopia

Clinical results with the Presby Drive®.

Scleral Expansion Band® (SEB) surgery is based on the Schachar theory of presbyopia. The theory states that the lens continues to grow at approximately 20 µm per year, eventually crowding the ciliary muscles and inhibiting their pulling action on the lens. Dr. Schachar proposed that expanding the area around the ciliary muscles (the reverse of a scleral buckle) would provide more room for the muscles to manipulate the lens, thereby increasing accommodative ability.

THE SURGERY
In this technique, we place four SEBs in the oblique quadrants of the eye to avoid cutting off any vascular flow to the anterior segment. Each tunnel is about 4 mm long and 1.3 mm wide, and is located 3.25 to 3.5 mm behind the limbus. The depth of the tunnel within the sclera is approximately 350 µm. To place the bands, we create punch incisions on the front and back of the tunnel using a foot-plated diamond blade. The implants themselves are flattened on the bottom to provide rotational stability, and have two grooves on either end that offer lateral stability.

MANUAL VERSUS AUTOMATED
This study investigates an automated technique for SEB surgery using the new Presby Drive®, an instrument that Presby Corp (Dallas, TX) has been developing over the course of a year (Figure 1). Performing the surgery manually takes about 40 minutes per eye, whereas performing it with the Presby Drive® takes about 15 to 20 minutes per eye. The Presby Drive® instrument uses a rotating circular blade with a footplate to make the cut, and eliminates measuring and other steps that diamond blades require. Whereas the manual surgery requires the additional steps of cauterization of bleeding that limit visualization, and marking 3.25 mm posterior to the limbus, the automated surgery simply involves making quadrant marks on peripheral cornea, and then a conjunctival dissection. I travel out of the country with US patients to perform the surgery, which I usually do on both eyes at the same time. I only have six patients who have had one eye operated on, and I have performed the surgery on 44 eyes of 25 patients, six monocular and 19 binocular. The age range for the FDA study is 50 to 65 years, but there have been patients as young as 42 who have undergone the surgery. My youngest patient to undergo this procedure was 45.

RESULTS
In the first month following surgery, there was somewhat more rapid visual recovery with the automatic technique. However, after 1 month, the results of the two surgeries appeared uniform. Some of the advantages that we found with the automated technique include an absence of cautery; an average reduction in surgical time of 40%; “quieter” eyes at the slit lamp during the postoperative period, with less subconjunctival hemorrhage; and all ocular steroid and antibiotic use was discontinued within the first postoperative week, as opposed to 2 to 4 weeks of use with the manual technique.

I have had positive follow-up in New York on 22 of the 44 eyes. We rated satisfaction by using a patient questionnaire, and the patients were generally satisfied with the results. Five patients out of 14 (36%) said that they are using their reading glasses half of the time for half of the activities that they did before, and eight patients (57%) are wearing reading glasses for less than 5% of the time. Ten of the patients (71%) stated that they were satisfied or very satisfied. There were two dissatisfied patients, one who had surgery performed on both eyes who had no improvement whatsoever, and one patient who didn't feel that he or she was doing very well. The patient who showed no improvement had the bands removed and returned to her preoperative state. We cannot determine at this time any reason why a patient would not respond to SEB surgery.

The use of Scleral Expansion Bands® and the Presby Drive® is not FDA approved in the US. All patients' surgeries were performed internationally or in the US with FDA IDE and New York Eye and Ear Infirmary IRB approval.
Barrie Soloway, MD, FACS, is Director of Vision Correction and Assistant Professor of Ophthalmology at the New York Eye and Ear Infirmary, New York, New York. Dr. Soloway may be reached at (212) 758-3838; bsolowaymd@pol.net
Adapted from Dr. Soloway's presentation, “Clinical Aspects of Surgical Reversal of Presbyopia,” hosted by BD Ophthalmic Systems on November 11, 2001 at the AAO Meeting in New Orleans, Louisiana.
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