A prospective, randomized, contralateral eye controlled study found that visual acuity and contrast sensitivity outcomes in patients undergoing bilateral cataract surgery with implantation of a multifocal IOL were improved by treatment pre- and postoperatively with topical cyclosporine ophthalmic emulsion 0.05% (Restasis, Allergan).
Dr. Donnenfeld investigated the potential benefit of topical cyclosporine treatment for optimizing cataract surgery/multifocal IOL implantation outcomes in a prospective, randomized, contralateral eye controlled study. Fourteen patients aged at least 50 years (mean, 66 years) undergoing bilateral phacoemulsification and implantation of a refractive multifocal IOL (ReZoom, Advanced Medical Optics) had one eye randomly assigned to twice-daily treatment with topical cyclosporine and used artificial tears (Systane, Alcon Laboratories) in the fellow eye.
The study agents were started 1 month prior to the first eye surgery, the second eye surgery was performed 2 weeks after the first, and use of the cyclosporine and artificial tears was continued for 2 months postoperatively. Vision outcomes included measurement of uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), and contrast sensitivity.
"All vision starts with the tear film, and an intervention that improves the tear film would be expected to improve quality of vision," said Dr. Donnenfeld, a private practitioner in Rockville Centre, NY. "That is particularly important for patients in whom multifocal IOLs are implanted. Because of the nature of their optics, those lenses may be associated with some degradation in quality of vision.
"Our study shows that topical cyclosporine A improves the tear film sufficiently to improve the optics of the eye, and it supports the idea that improving the tear film is the most important step clinicians can take in improving visual outcomes in multifocal IOL recipients," he added.
The inclusion criteria for the study required patients to be aged at least 50 years, have a visual potential of 20/25 or better, and be considered likely to complete all study visits. Patients with any history of topical cyclosporine treatment or with known contraindications to the study agents were excluded.
The 14 study participants ranged in age from 56 to 75 years and comprised nine women and five men. Mean preoperative logMAR UCVA and BCVA values were 0.27 and 0.70, respectively, in the cyclosporine-treated eyes, and 0.26 and 0.79, respectively, in the artificial tears-treated eyes.
No significant differences were seen in preoperative UCVA or BCVA between the two treatment groups. At the end of the treatment period, however, visual acuity outcomes were significantly better in the cyclosporine-treated eyes compared with the controls for both mean logMAR UCVA (cyclosporine, 0.11; artificial tears, 0.19; p = 0.045) and mean logMAR BCVA (cyclosporine, 0.0; artificial tears, 0.1; p = 0.005).
Contrast sensitivity was evaluated under mesopic and photopic conditions with and without glare. In all test scenarios, the outcomes were better in the cyclosporine-treated eyes, and the differences favoring the cyclosporine-treated eyes compared with the control eyes were statistically significant or trended toward statistical significance for several of the measurements.
In addition, a statistically significant difference favored the cyclosporine-treated eyes in patient satisfaction ratings. Ten patients (71%) expressed a preference for one eye versus the other, and among those patients, the cyclosporine-treated eye was preferred 4:1 over the eye treated with artificial tears.
"The new multifocal IOLs are well-tolerated in most patients, but multifocal optics can still lead to glare and halo with a loss of contrast sensitivity," said Dr. Donnenfeld. "Any additional compromise of the visual system, such as ocular surface disease, may further reduce contrast sensitivity while increasing unwanted visual symptoms, and that predisposition may be a particular concern in the generally older population of cataract surgery patients."
Assessments of dry eye also were performed, including measurement of tear breakup time and Schirmer scores. The results at the end of the study also were more favorable in the eyes treated with topical cyclosporine, although the differences compared with the artificial tears-treated eyes were not statistically significant.