Artisan myopia and hyperopia ‘doing well’ in phase 3 trials

The Artisan lens for myopia and hyperopia are both in phase 3 trials and seem to be performing relatively complication free.

BOSTON — The Artisan hyperopia and myopia lenses (Ophtec USA, Boca Raton, Fla.) are performing well, according to results of studies presented at the annual American Society of Cataract and Refractive Surgery meeting. Both lenses are now in phase 3 trials and have shown to be very safe and effective treating eyes from +12 D to +3 D and -5 D to - 20 D, according to Ophtec officials and clinical investigators.

The hyperopia Artisan lens has leapfrogged the phase 2 study requirements this year to enter phase 3 trials, according to Maurice E. John, MD, who presented the interim results of the hyperopia study.

The phase 3 2-year study has now begun with a 550 subject, prospective multicenter study, sponsored by Ophtec USA.

The lenses are available from +3 to +12. Dr. John said he considers the Artisan the most challenging IOL to implant.

Very good interim results

From February to October 1999, 10 subjects received 14 lenses. The study population consisted of nine females and one male with a mean age of 39.9 years. The mean preoperative spherical equivalent was +6.8 D and the mean power of the lens was +6.6 D.

All of the participants in the study achieved an uncorrected visual acuity (UCVA) of 20/40 or better postoperatively and all eyes achieved best spectacle corrected visual acuity (BSCVA) of 20/25 or better. No eyes lost any lines of BSCVA. Nearly three-quarters of those enrolled achieved correction within 0.5 D of the intended goal, while 90% were within 1 D of the goal. Endothelial loss after 6 months was 0%. No complications or adverse events were reported.

The preferable anterior chamber depth for the IOL is 3.2 mm. The mean anterior depth average was 3.3 mm. For both the myopia and hyperopia lenses, Dr. John said be believed the best approach is temporal. He makes a 5.2-mm incision, and the surgery usually lasts 21 to 30 minutes.

Of the complications that did present, two patients developed posterior synechia and one patient presented at 6 weeks postop with fibrin pupillary membrane. All of these patients were treated with topical steroids, all improved dramatically and are now stabilized and off medication without any effects on visual acuity. All three of these patients had relatively shallow anterior chamber depths in the 3.2 mm range. In Europe cases apparently are done with anterior chamber depths down to 2.6 mm. Ultrasound and Orbscan [Bausch & Lomb Surgical, Claremont, Calif.] measure anterior chamber depths from the front of the cornea to the front of the lens. This does not take into effect the vault of the iris, the thickness of the iris and the cornea. Dr. John strongly suspects the ideal patient is one with a relatively flat iris, relatively thin iris and a relatively thin cornea. There, of course, may be other factors involved.

He said the short-term hyperopia lens and almost 3-year myopia lens results have been outstanding. The lens shows good resistance to endothelial loss. But he said doctors must learn a little bit more about patient selection, especially in those patients with relatively cramped anterior segment anatomy. Overall Dr. John is thrilled with the results in his myopic and hyperopic patients.

The results of a Brazilian study that included speaker I. Walton Nosé, MD, confirmed the positive results of both U.S. studies. The clinical study took place at 20 different sites in Brazil. The subjects were chosen using U.S. Food and Drug Administration study parameters.

Dr. Nosé presented the clinical results of 25 patients, with nearsightedness of 5 D to 10 D and maximum astigmatism of 2 D. His study used lenses available from 3 D to 12 D in 0.5 D increments.

In the Brazilian study, the spherical refraction dropped from 8.26 D to –0.26 postop, and 62% of eyes were within 1 D of goal correction. All eyes were within 2 D.

Also, 88% of eyes maintained or gained BSCVA; only one eye lost two lines. The UCVA was 20/40 or better in 38%, and 62% were within 20/50. Pupil shapes remained normal in all but one eye, and that eye was corrected at 1 month. There was localized iris atrophy in two eyes, and one eye showed endothelial loss.

“The Artisan can be considered a good option with hyperopes. The lens is adjustable, predictable and reversible,” said Dr. Nosé, who also said that the surgical technique took extensive training.

Good success, still complications

Even with all the good results of the Artisan lens, there have been complications. According to Paulo M. Marques, MD, the complications are usually fixable.

He studied the complications affecting high myopes. The European myopia inclusion criterion was an interior depth to 2.6 mm and endothelial cell count of 2,200 cells per mm. His study contained 112 eyes of 65 patients with the 5-mm myopia lens from 8 D to 26 D. The 6-mm optical zone group included 44 eyes of 20 patients from 10 D to 16 D of myopia.

He reported excellent overall safety using the lenses with more than two lines gained in all patients and no lines lost in any patients.

Of the complications he saw, it appeared that patient selection was the most important criterion. He suggested staying away from patients without stable refractive error and avoiding patients with large pupil size and unrealistic expectations. He explained that he uses three to four suture knots to close the incision to prevent leakage and also to avoid inducing astigmatism.

During surgery, he explained that a weak grasp of the claws of the Artisan was the worst case scenario, potentially resulting in decentration. However, readjustment before closure is not difficult and after closure can be done through a clear corneal incision of 2 mm.

Dr. Marques reminded doctors to always grasp the iris farthest from the pupil. “It’s always easy to do a re-grasp.”

The study results showed eight cases of glare and halos, five due to decentration and three to large pupils. There were cases of decentration.

Endothelial cell loss averaged about 3.2%, and there was no difference between both models. There were two cases of chronic inflammation.

“Prevention of complications is best controlled by using good surgical techniques and proper evaluation. The 6-mm lens seems to provide less glare and halo effects. Sizing is not a problem, and remember that all complications are surgeon related,” Dr. Marques said.

For Your Information:

Maurice E. John, MD, can be reached at John Kenyon Eye Center, 1305 Wall Street, Ste. 200, Jeffersonville, IN 47130; (812) 288-9011; fax: (812) 288-7479; e-mail: jkecaa@aol.com. Ocular Surgery News could not confirm whether or not Dr. John has a direct financial interest in any of the products mentioned in this article or if he is a paid consultant for any companies mentioned.

I. Walton Nosé, MD, can be reached at Av Republica do Libano 034, San Paulo, 04502-001, Brazil; (55) 11-884-2020; fax: (55) 11-884-8494; e-mail: wnose@pobox.com.

Paulo M. Marques, MD, can be reached at Av. Villagarcia de Arosa, 1983 1 Esq. Fte., 4450 Matosinhos, Portugal; (351) 2-9385455; fax: (351) 2-9385455; e-mail: mesquitam@mail.telepac.pt. Dr. Marques has no direct financial interest in any of the products mentioned in this article, nor is he a paid consultant for any companies mentioned.

Ophtec USA can be reached at 6421 Congress Ave., Ste. 112, Boca Raton, FL 33487; (561) 989-8767; fax: (561) 989-9744.