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Some surgeons treating
all patients scheduled
for surgery

Results from one study
of Restasis use in LASIK
patients.
Source: Karl Stonecipher,
M.D.
Ophthalmologists have generally treated LASIK patients’ post-op dry-eye complaints as they have developed.
Some physicians are rethinking that approach by pro-actively treating dry eye before and after LASIK in patients with and without symptoms and signs of dry eye.
“I think the change of the guard is we’re going to treat more of these patients pre-operatively,” said Karl Stonecipher, M.D., Greensboro, N.C.
This proactive stance is prompted by recent research that shows better post-op outcomes in patients that have alleviated their dry-eye symptoms. The latest related study was published in the Journal of Cataract & Refractive Surgery and showed that in 21 dry-eye patients (42 eyes), certain dry-eye treatments provided a greater refractive predictability three and six months post-op. The study was led by George M. Salib, M.D., Los Angeles; Marguerite B. McDonald, M.D., clinical professor, Tulane University School of Medicine, New Orleans; and Michael Smolek, Ph.D., Louisiana State University School of Medicine, New Orleans.
Patients in the study were divided into two groups and treated with cyclosporine 0.05% ophthalmic emulsion (Restasis, Allergan, Calif.) or unpreserved artificial tears, both for twice a day for one month before surgery and three months post-op. Patients could use the tears more often if necessary.
Study patients had a mean age of 47 years old, and 90% were women. All patients were diagnosed with dry eye before surgery, with mean Schirmer scores with anesthesia of 6.3 mm in the artificial tears group and 5.6 mm in the Restasis group.
Investigators found differences between the two groups when they measured their postoperative refractions compared to their refractive targets.
“The MRSE [mean refractive spherical equivalent] in the cyclosporine-treated group was significantly closer to its intended target three and six months after surgery than was the MRSE in the artificial-tears-treated group,” the investigators wrote. The Restasis group also had a statistically significant greater percentage of patients within 0.5 D of their target refractions at three months, Dr. Salib said.
The Ocular Surface Disease Index , or OSDI, scores started to decrease at one month for the Restasis patients and at three months for the patients using only artificial tears compared with baseline.
There was no significant difference in the uncorrected visual acuities or Schirmer test results when comparing the two groups.
Dr. McDonald said she and the fellow investigators decided to research LASIK and dry-eye treatment after other researchers found 100 patients had better post-op LASIK visual outcomes after Restasis use. In that study, 63% of patients reported post-op dry-eye symptoms, although they looked clinically normal under the slitlamp, she said. That research was presented at the 2005 annual meeting of the Association for Research in Vision and Ophthalmology.
In that study, “[the investigators] did not pre-treat dry eye. I had desperate dry-eye patients receiving pre-treatment for a month and then three months after surgery.
Clinical practices
The study results prompted Dr. McDonald to start all of her pre-op refractive surgery patients (she performs surface ablation) on Restasis at the time they book surgery.
“Most book a couple of weeks in advance, so they get [the drops] at least two weeks. Others are on it for a month,” she said. Depending on their post-op dry-eye condition, she will continue the drops for another three months after surgery.
Pre-op and post-op dry-eye treatment with all refractive surgery patients may become the norm.
“The patient is more tolerant and has a better outcome if you optimize the surface ahead of time,” said Robert L. Latkany, M.D., Dry Eye Clinic, New York Eye and Ear Infirmary, New York. However, it is critical that patients use a medication like Restasis long enough to see an effect, Dr. Latkany said. This means a minimum of one month pre-op and four to six weeks post-op, he said.
For now, many physicians are experimenting with more aggressive dry-eye treatment in patients with pre-op symptoms and signs and continuing the treatment after surgery. For instance, Steven E. Wilson, M.D., director of corneal research, Cole Eye Institute, Cleveland, uses Restasis in about 25% of his LASIK patients for one month pre-op and then re-evaluates them at one-month intervals up to six months.
“Seventy-five percent to 80% have complete resolution of all signs, even staining,” he said.
Many of his LASIK patients are borderline dry eye and eventually need treatment, he said. “When we perform LASIK, it tips them over the edge. They often develop a full-blown LASIK-induced dry eye,” he said.
Eric D. Donnenfeld, M.D., Rockville Centre, N.Y. uses Restasis for two weeks pre-op and three months post-op in dry-eye patients, peri- and menopausal women, and contact-lens intolerant patients. The one downside to Restasis use for patients is the cost or co-pay for the medicine, he said. Physicians should also prepare patients that they may use the medication for a long period of time, Dr. Wilson said.
Dr. Stonecipher also uses Restasis with dry-eye surgical patients but has a few other pearls to help these patients. “If a severe dry-eye patient comes for surgery in the winter, I tell them to come back in the summer,” he said. The humidity of the summer will help their condition, he said. He also will prescribe Pred Forte (prednisolone acetate, Allergan) or Zymar (gatifloxacin, Allergan) pre-op four times a day for three days and has noticed a difference in post-op day one vision. He believes the medications may clean the eyelid margins or reduce inflammatory products from the tear film.
Future research in dry-eye treatment and LASIK may investigate the incidence of post-op flap melt, DLK, regression of effect, or microbial keratitis and Restasis use, Dr. Salib said. These complications are associated with post-op inflammation and dry eye, Dr. Salib said.
Editors’ note: Dr. Donnenfeld is a consultant for Advanced Medical Optics (AMO, Santa Ana, Calif.), Alcon (Fort Worth, Texas), Allergan, and Bausch & Lomb (Rochester, N.Y.). Drs. Latkany and Salib have no financial interests related to their comments. Dr. McDonald is a consultant for Allergan, Refractec (Irvine, Calif.), Santen (Napa, Calif.), and various other companies. Dr. Stonecipher is a consultant for Alimera Sciences (Alpharetta, Ga.), Allergan, IntraLase (Irvine, Calif.), and Nidek (Fremont, Calif.). Dr. Wilson is a consultant for Allergan.
Contact Information
Donnenfeld: 516-766-2519, eddoph@aol.com
Latkany: 212-832-2020, relief@dryeyedoctor.com
McDonald: 504-232-3641, margueritemcmd@aol.com
Salib: gsalibmd@yahoo.com
Stonecipher: 336-402-2500, stonenc@aol.com
Wilson: 216-444-5887, wilsons4@ccf.org
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