Frequently Asked Questions
About the AcrySof® ReSTOR® IOL
Here are some of the most common questions that eye care professionals have about the new AcrySof® ReSTOR® lens. Please contact your Alcon Surgical Account Manager for additional information about how this breakthrough IOL can benefit your patients.
Visit the patient FAQ section for answers to common questions from patients.
How does the AcrySof® ReSTOR® IOL work?
The AcrySof® ReSTOR® IOL is designed to provide vision similar to the pre-presbyopic human lens. It works by using apodized diffractive and refractive technologies to provide a full range of vision.
back to top
What is apodization?
Apodization is a gradual reduction or blending of the diffractive step heights. This unique technology optimally manages light energy delivered to the retina because it distributes the appropriate amount of light to near and distant focal points, regardless of the lighting situation. The AcrySof® ReSTOR® IOL's apodized diffractive optic is designed to improve image quality while reducing visual disturbances compared to prior multifocal technologies.²
back to top
How does the AcrySof® ReSTOR® IOL provide for near vision?
Light rays from a near object diverge as they enter the eye. The AcrySof® ReSTOR® IOL uses the central apodized diffractive region and +4.0 D correction to focus a clear image on the retina.
back to top
How does the AcrySof® ReSTOR® IOL provide for distance vision?
Light rays from a distant object are parallel as they enter the eye. The AcrySof® ReSTOR® IOL uses both the central
apodized diffractive and peripheral refractive regions of the optic to focus the
distance image on the retina.
back to top
How does the AcrySof® ReSTOR® IOL perform for intermediate vision?
Clinical study results demonstrate that patients have good intermediate vision for daily tasks, such as applying make-up, shaving, reading labels on a shelf and viewing a computer monitor. 85% of the AcrySof® ReSTOR® IOL patients achieved functional uncorrected intermediate vision of 20/40.
4 At this level, patients can read the normal type in a newspaper, and are able to pass the vision test for a driver's license in most states.
back to top
What were the results of contrast sensitivity studies?
Studies on the
contrast sensitivity of the AcrySof® ReSTOR® IOL indicated that at lower spatial frequencies, there was no clinically or functionally significant difference between AcrySof® ReSTOR® and monofocal control subjects. Other studies indicate that these lower spatial frequencies are most important in terms of vision related to everyday life skills, such as walking, driving and reading.
1
back to top
How does pupil size affect near and distance vision?
The AcrySof® ReSTOR® IOL effectively restores
near and distance vision, regardless of pupil size. In bright light, with constricted pupils, the lens sends light energy simultaneously to both near and distant focal points. In low light with dilated pupils, the apodized diffractive lens sends a greater amount of energy to distance vision to minimize
visual disturbances.
back to top
Does the AcrySof® ReSTOR® IOL work well for night vision?
In dim or dark lighting conditions, patients with the AcrySof® ReSTOR® IOL may experience glare or halos, although the majority report the incidence to be easily tolerated. This is due to a patented² technology, called
apodization. However, surgeons are cautioned against implanting the AcrySof® ReSTOR® IOL in professional drivers or for patients who have lifelong complaints about nighttime glare.
back to top
Are there visual disturbances associated with the AcrySof® ReSTOR® IOL?
The AcrySof® ReSTOR® IOL features a technology called
apodization, which is designed to reduce the frequency and severity of
visual disturbances. Apodization is the gradual reduction in step heights of the diffractive elements of the lens. While some patients may still experience visual disturbances, their occurrence is greatly reduced due to the absence of sharp junctions or large steps in the apodized diffractive lens.
back to top
Are there studies on AcrySof® ReSTOR® IOL performance?
Yes. The clinical study demonstrates that the AcrySof® ReSTOR® IOL has the ability to substantially restore a cataract patient's ability to see both near and distant objects, without the aid of reading glasses or bifocals. 80% of these patients reported not needing glasses following bilateral implantation. Additionally, it was shown that nearly 94% of the study subjects would have the AcrySof® ReSTOR® IOL implanted again.
back to top
Is the AcrySof® ReSTOR® IOL safe?
Yes. The FDA has determined that the AcrySof® ReSTOR® IOL is both safe and effective. The AcrySof® ReSTOR® IOL uses the same
biomechanical/biomaterial platform as the
AcrySof® Single-Piece Platform, which – as of August 2007 – has been safely used in over 25 million human eyes. Studies on the original monofocal AcrySof® Multipiece lenses have demonstrated a high level of material biocompatibility within the eye.
3
back to top
Are there any adverse effects with the AcrySof® ReSTOR® IOL?
The incidence of cumulative adverse events for the AcrySof® ReSTOR® IOL in the clinical study compared favorably to the FDA historical grid rates. A single occurrence of pupillary block exceeded the FDA grid rate. No occurrences of persistent adverse events were observed in any of the study patients implanted with the AcrySof® ReSTOR® IOL.
back to top
Are biometric techniques for the AcrySof® ReSTOR® IOL different from those of monofocal lenses?
There is minimal differences with the
biometry for the AcrySof® ReSTOR® IOL compared to the techniques used for any other available AcrySof® lenses. As with any IOL, accurate biometry is essential for the overall success of the AcrySof® ReSTOR® IOL. It is important to target emmetropia, and to personalize the A-constant for all IOLs.
back to top
Is implantation of the AcrySof® ReSTOR® IOL lens different than implantation of any other IOL in the AcrySof® family of lenses?
The AcrySof® ReSTOR® IOL is implanted using the same technique as the
AcrySof® Single-Piece IOL.
back to top
What is the A-constant for the AcrySof® ReSTOR® IOL?
- The suggested A-constant for the SN60D3 model is 118.1
Refer to the product specifications for additional details.
back to top
What is the A-constant for the AcrySof® ReSTOR® Aspheric IOL?
- The suggested A-constant for the SN6AD3 model is 118.9
Refer to the product specifications for additional details.
back to top
Does the AcrySof® ReSTOR® IOL use the same materials and technology as the AcrySof® platform?
Yes. The AcrySof® ReSTOR® IOL uses the same biomechanical/biomaterial platform as the AcrySof® Single-Piece Platform, which – as of August 2007 – has been safely used in over 25 million human eyes.
back to top
Is the procedure covered by Medicare or other medical insurance?
Partially. The Centers for Medicare and Medicaid Services (CMS) clarified its payment rules to present Medicare beneficiaries with the choice to receive presbyopia-correcting IOLs, such as the AcrySof® ReSTOR® IOL. Under the new policy, Medicare will continue existing reimbursement amounts for cataract surgery, and patients may elect to pay additional charges for advanced technology lenses such as the AcrySof® ReSTOR® IOL.
For more details about reimbursement for the AcrySof® ReSTOR® IOL, please reference the
CMS reimbursement release.
back to top
Which patients are best suited for implantation?
Proper patient selection is a key factor in ensuring successful outcomes with the AcrySof® ReSTOR® IOL. Age, degree of general alertness, ocular pathology, and functional and occupational requirements must all be taken into account. Certain subjective characteristics, such as realistic expectations and the desire to be free of glasses, must also be considered.
back to top
Are there studies on patient satisfaction?
Yes. The clinical studies demonstrate that the AcrySof® ReSTOR® IOL not only offers a high level of spectacle freedom, but also carries a remarkably high patient satisfaction rate. In fact, nearly 94% of study subjects said they would have the AcrySof® ReSTOR® IOL implanted again. More information may be found in the clinical studies section of this Web site.
back to top
Can the AcrySof® ReSTOR® IOL be implanted in the second eye if the patient already has a monofocal lens in the other eye?
Previous implantation is an important medical concern to patient selection. Please refer to the
patient selection criteria discussed in this Web site.
back to top
What must a physician do to gain access to the lens?
Please contact your Alcon surgical representative.
back to top
What does the training entail?
This training program will cover the
AcrySof® ReSTOR® IOL technology, optical principles, how AcrySof® ReSTOR® differs from the competition,
patient selection, keys for success and
reimbursement. Alcon is providing the training free-of-charge. However, physicians will be required to pay all of their travel related expenses. After attending the training program, physicians should be able to:
- Understand and describe apodized diffractive IOL technology
- Discuss clinical trials for new application of the technology
- Develop a patient selection system that will allow for better patient outcomes and increased patient satisfaction
- Develop strategies for incorporating refractive IOLs into their practice
back to top
How will Alcon assist in practice marketing?
If you have attended one of the training programs, you will have access to the online AcrySof® ReSTOR® IOL Practice Performance Zone (PPZ). You can access the PPZ by clicking the link in the left menu of this page, or by accessing the link at
http://www.acrysofrestor.com/ppz. Additional items are being explored, and will include brochures, ad templates, press release templates, and office materials. Speak with your local Alcon surgical account manager regarding the full complement of offerings.
back to top