MULTIFOCAL CONTACT LENSES
Air Optix Aqua Multifocal Contact Lenses in Practice
Reviewing results from a pre-market evaluation
By Joseph Rappon, OD, MS, FAAO and Peter Bergenske, OD, FAAO
Ciba Vision recently launched Air Optix Aqua Multifocal contact lenses, a new silicone hydrogel soft contact lens for the correction of presbyopia. This monthly replacement lens is made from lotrafilcon B, the same material used for Air Optix Aqua contact lenses. This multifocal system incorporates three different ADD powers (LO, MED, HI) to correct all stages of presbyopia. Air Optix Aqua Multifocal contact lenses are available in one base curve (8.6) and one diameter (14.2). The distance power ranges from +6.00D to −10.00D, available in 0.25D steps. Fitting guidelines have been devised to assist practitioners in selecting the initial lenses to fit patients, and for further modifying these selections if necessary.
Several clinical trials were conducted during the ideation and development of this new product. Additionally, Ciba Vision conducted a large pre-market evaluation to assess the in-market performance of Air Optix Aqua Multifocal contact lenses and capture practitioner feedback and fitting information.
A pre-market evaluation is distinctly different from a clinical trial in that, rather than follow a strict protocol, practitioners are given limited guidelines and are free to select patients and perform procedures as they would in routine practice. Commercial lens inventories were fit according to their intended use. The study was exempt from IRB written, informed consent.
The goal of the pre-market evaluation was to assess practitioners' satisfaction with Air Optix Aqua Multifocal contact lenses and to validate the steps outlined in the fitting guidelines. These were measured in terms of practitioners' impressions of ease of fit and reported success rate.
Approximately 350 practitioners in the United States received complimentary trial lens sets and were invited to report on their experience with fitting Air Optix Aqua Multifocal contact lenses on 10 patients each. The Air Optix Aqua Multifocal fitting guide was supplied along with the trial lens sets.
It was suggested that the ideal patient for this evaluation would be a symptomatic presbyope for whom they would prescribe +2.00D or less add power in spectacles. A follow-up appointment was recommended to be scheduled for about 4 weeks after dispensing, however, additional follow-up appointments may have been scheduled according to patient or practitioner needs. Product fitting was evaluated at the initial visit and the 1-month follow-up visit.
Our survey evaluated two outcomes. Ease of fit was determined by the following: number of trial lenses required per subject successfully fitted, number of office visits required to determine success/failure, agreement with ease-of-fit statements.
Success rate was determined by the following: proportion of patients successfully fit, intent to recommend Air Optix Aqua Multifocal contact lenses, change from baseline in choice of preferred soft contact lens multifocal correction.
The average number of trial lenses and office visits required to determine successful fit was calculated. Practitioner agreement on "ease of fit" (5-point scale) reported on the end-of-evaluation questionnaire was analyzed using the Exact Binomial Test. Responses were collapsed to "yes" (strongly/somewhat agree) and "no" (strongly/somewhat disagree), and percent of "yes" was tested against 50%.
The proportion of successfully fit patients was defined as the number of successful patients as indicated by the practitioner, divided by the total number of patients the practitioner attempted to fit during the evaluation period. Purchase intent and intent to continue prescribing Air Optix Aqua Multifocal contact lenses were also tabulated descriptively, with no inferential testing.
A total of 2,455 patients were evaluated by 294 practitioners participating in this evaluation. Of those, 1,985 were current contact lens wearers, and 452 were not contact lens wearers (18 not specified).
EASE OF FIT
On average, practitioners required 2.4 visits and less than 4 lenses per patient to successfully fit the Air Optix Aqua Multifocal lenses. All of the final agreement statements tested were found to be statistically significant. Among those practitioners expressing agreement or disagreement, percent of agreement was significantly higher than 50 percent.
In terms of practitioner agreement statements, 95.1% of practitioners agreed that Air Optix Aqua Multifocal contact lenses are easy to fit. In fact, 64.3% agreed they're as easy to fit as spherical lenses and 65.6% agreed they're as easy to fit as monovision lenses.
Additionally, 4 out of 5 practitioners agreed that Air Optix Aqua Multifocal lenses are easier to fit than other multifocal soft contact lenses, and 79.7% agreed that Air Optix Aqua Multifocal lenses have a higher success rate than other multifocal soft contact lenses.
Furthermore, 70.6% of practitioners agreed that Air Optix Aqua Multifocal lenses fit most patients on the first try (Figure 1).
Figure 1. Practitioner Agreement with Ease of Fit Statements for Air Optix Aqua Multifocal Contact Lenses.
Although the practitioners were asked to target patients with add powers not more than +2.00D, review of the distribution of spectacle add powers for patients fit in this evaluation shows that nearly 60% of patients fit during the evaluation period had spectacle adds of 02.00D or greater (Figure 2).
Figure 2. Distribution of Spectacle Adds.
An impressive 89.6% of practitioners agreed Air Optix Aqua Multifocal lenses will be their preferred multifocal soft contact lens in their practice.
An astounding 96.0% of practitioners also agreed they would recommend Air Optix Aqua Multifocal lenses to other practitioners, and 96.8% agreed that they would recommend Air Optix Aqua Multifocal lenses to their presbyopic patients (Figure 3).
Figure 3. Practitioner Agreement with Intent to Recommend Air Optix Aqua Multifocal Contact Lenses.
Finally, the most remarkable finding in this evaluation was the practitioners� most preferred multifocal soft contact lenses. After the conclusion of the PME, 80.6% of the practitioners listed Air Optix Aqua Multifocal as their most preferred multifocal contact lens (P<0.001) (Figure 4).
Figure 4. Effect of PME on Most Preferred Eye Care Practitioner Preference for Multifocal Contact Lens Brands
Overall, Air Optix Aqua Multifocal lenses performed well in this pre-market evaluation. While "ease of fit" has no defined standards, clearly these experienced practitioners found the ease of fit of this product to be highly acceptable. Likewise, "success" may have many definitions, because sometimes our concept of the performance according to clinical measures can contrast markedly with patient purchase intent.
When asked at the outset their estimated success with soft multifocals in general, this group estimated success with the category to be only about 65%. The 76% success rate achieved with Air Optix Aqua Multifocal lenses is likely the reason why practitioners' intent to recommend this product was extraordinarily high. Furthermore, it can be reasonably expected that if this group of practitioners had stayed within the target range of spectacle add powers less than +2.00D, the success rate would have been even higher than the 76% achieved in this evaluation.
It's quite rare that a new product is met with true enthusiasm and has the potential to expand the numbers of successful patients. Presbyopia offers tremendous opportunity for practitioners equipped to provide this large and motivated patient group with successful contact lens correction. In order to accomplish this, the ideal new product must be easy to use and highly successful.
Air Optix Aqua Multifocal contact lenses show every sign of being a product that can deliver this kind of performance and should be a welcome addition to every practice.
|DR. RAPPON (LEFT) WAS THE LEAD CLINICAL PROJECT MANAGER FOR AIR OPTIX AQUA MULTIFOCALS AND IS A MANAGER OF CLINICAL RESEARCH IN THE GLOBAL CLINICAL AFFAIRS GROUP AT CIBA VISION. DR. BERGENSKE (RIGHT) IS DIRECTOR OF PROFESSIONAL SUPPORT FOR CIBA VISION NORTH AMERICA.|