Wednesday, August 8, 2007

Restasis Run Around

A randomized paralled double-masked prospective clinical trial published in the May 2006 Journal of Cataract and Refractive Surgery, found that Restasis (cyclosporine 0.5%) had no effect on 21 dry eye post-op LASIK patients (42 eyes), as indicated by the Ocular Surface Disease Index Questionaire, nor were there changes in best corrected visual acuity in the LASIK post-op dry eyes treated with Restasis vs. those treated with unpreserved aritifcial tears.

The study reported that mean refractive spherical equivalent in cyclosporine-treated eyes was significantly closer to the intended target at 3 and 6 months after surgery than in artificial-tears-treated eyes. The reported P value of this hypothesis was .007.

In spite of the above evidence, the study authors conclusion was, "Restasis provides refractive predictability for the dry eye patient 3 and 6 months after surgery. "

This questionable conclusion seems to be based on an unidentified (key word) precentage of cyclosporine eyes that was within +/- 0.5 D of the refractive target 3 months after surgery compared to the artificial tears treated eyes.

An obvious question: Could the conclusion be a bit of a stretch given that the p value was not all that significient, and the study did not have a control, so maybe neither Restasis or unpreserved dry eye drops make much difference compared to no therapy.


Penny said...

Why all the hoopla about visual predictability (accuracy?) with Restasis? My doctor took me off it before my Lasik because it stung like crazy, and the Lasik went well and my vision did fine. I'm certainly not going back on that stuff.

Jeff Anshel, OD said...

Based on this weak study result, it seems that Allergan started marketing Restasis as a viable pre and post-op therapy to prevent LASIK related dry eyes.

This is disconserting on a number of levels-the first being that Restasis was originally detailed to eye care professionals as a therapy that can take up to 90 days to kick in.?

The second being the cost involved. Restasis therapy cost the dry eye patient more than $100.00 per month, if used as directed. My experience with Restasis has been hit and miss, at best.

The third being Restasis inhibits T-cell production on the ocular surface, which puts the user at a higher risk of developing ocular herpes...should they unknowingly be exposed to the herpes type 2 virus that affects over 20% of the adult population in this country, according to the Center for Disease Control in Atlanta.

Dry eye Harry said...

Hey, Is a .007 P value a big or a small one, in the scheme of this study?

August 9, 2007 6:17 PM

Anonymous said...

Restasis has been great for many of my patients. I have had many of my post lasik patients, contacts lens intolerate, and woman on various meds try various Artifical Tears and found that many times they just get worse over time. Restasis eliminated the issue and I have found many of my patients refer their friends with dry eyes.

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