MultifocalS: A Reference Guide Your complete resource for advanced technology IOL implantation, from patient selection to post-op evaluation For best results, use this comprehensive guide from start to finish for at least five bilateral cataract cases.
Focused Patient Selection Biometry Guidelines For successful refractive outcomes in ATIOL implantation, accurate pre-op evaluation is critical. Patient selection should be based on: Accurate candidacy, biometry and ocular health status assessment Lifestyle and visual preferences Capability of maintaining reasonable expectations The following biometry data collection sheet, candidacy evaluation form and patient lifestyle questionnaire, used in conjunction with the decision tree on page 4, will help simplify the patient selection process by assisting you in choosing the lens best suited to your patient. Accurate preoperative assessment of biometry is essential to properly determine ATIOL candidacy. Refraction: Target emmetropia for optimal visual performance and refractive outcomes - Astigmatism must be managed to less than 0.5 D postoperatively Use a new generation IOL calculation formula, such as the Holladay 2 or SRK/T formulas Carefully consider A-Scan* biometry method options: - Contact/applanation: Can cause corneal compression, resulting in an artificially shortened axial length, resulting in a myopic outcome - Immersion: Can be variable based on administrator; should be consistent/reproducible and more accurate than contact/applanation - Optical coherence (LENSTAR or IOLMaster * ): Highly accurate; may not measure through dense cataract - Recheck if the difference in axial length between the two eyes is >0.2 mm - An axial length measurement that is erroneous by 1 mm will cause a postoperative refractive error of ~3.0 D In my experience, 50% of surgeons postoperative surprises are A-Scan * related. Personalize lens constants to compensate for the differences in instrumentation, measurement technique and IOL power calculation methods Keratometry/Corneal Status: Discontinue contact lens wear until stable keratometry readings are confirmed (typically 2 4 weeks for soft lenses, longer for hard contacts) Use one dedicated keratometer for all pre- and post-op measurements - Manual keratometry may be more accurate than automated methods (such as topography, hand-held or IOLMaster * ) Automated Ks are acceptable as long as they are consistent Ensure corneal examination is normal (applies to multifocal assessment only) - E.g., there should be no significant guttata or epithelial dystrophy Check keratometry readings - Use topography to confirm irregular readings - If readings are consistently irregular, do not proceed with ATIOL implantation Recheck keratometry if: - Readings are <40.0 D or >47.0 D (<40.0 D may indicate previous refractive surgery) - Astigmatism measured correlates poorly with refraction Dr. Olsen If K-readings are off by 1.0 D, this will result in ~1.0 D shift in post-op refraction. 1 Calculation of Lens Power: Should be determined by surgeon experience, preference and intended lens placement - Recheck if there is >2.0 D difference in lens implant powers between eyes *Trademarks are the property of their respective owners. LENSTAR is a registered trademark of Haag-Streit.
Focused Patient Selection Biometry & Candidacy Assessment Consider using a form like the sample below to record patient biometry and determine ATIOL candidacy. Biometry and candidacy data collection form (front & back to be completed by surgeon and placed in patient record) Biometry Data Sample Form Patient Name: Date: / / 1. Refraction: Pre-op: OD (right eye): D D x (SPHERE) (CYLINDER) (AXIS) Example: -0.5 D +1.0 D x 90 indicates: OS (left eye): D D x (SPHERE) (CYLINDER) (AXIS) -0.5 D spherical portion (myopia/hyperopia) +1.0 D cylinder portion (astigmatism) 90 axis of the cylinder Post-op: OD (right eye): D D x (SPHERE) (CYLINDER) (AXIS) TEAR HERE OS (left eye): D D x (SPHERE) (CYLINDER) (AXIS) 2. Targeted post-op spherical equivalent (usually circled on A-Scan printout): OD (right eye): D OS (left eye): D 3. Axial Length: OD (right eye): D OS (left eye): D 4. Difference in Axial Length between OD (right eye) and OS (left eye): D i. If >0.20, was the result confirmed through new measurement? Y / N 5. Pre-op K-readings: OD (right eye): K1 D _K2 D (STEEP AXIS) (FLAT AXIS) OS (left eye): K1 D _K2 D (STEEP AXIS) (FLAT AXIS) 6. How will you correct astigmatism, if present, to <0.5 D during or after surgery? 7. A-Constant used: (Continued on back) 2
Focused Patient Selection Biometry & Candidacy Assessment (Continued) Sample Form Multifocal Candidacy Questionnaire Answers in bold green suggest strong candidacy. Red responses suggest the patient may not be an ideal candidate for an ATIOL, though ultimate recommendation is at the surgeon s discretion. 1. Does the patient s lifestyle questionnaire indicate a desire for reduced spectacle dependence for any activities? Y / N 2. Can less than 0.5 D of astigmatism be achieved post-op? Y /Y / N Remember: Your incisions may impact astigmatism during the procedure. 3. Has the patient had previous refractive surgery (PRK, RK or LASIK)? Y / N Previous refractive surgery can result in unstable, inconsistent measurements. 4. Does the patient wear contact lenses? i. If so, did the patient have their contacts out for 2-4 weeks prior to biometry? Y / N ii. Were K-readings and topography measurements taken to establish stability? Y / N Prolonged hard lens wear can result in continuing changes in the shape of the cornea. 5. Does corneal topography confirm corneal regularity? Y / N Patient history/topography report should detail irregularities such as keratoconus or corneal scars. 6. Could dry eye be present? Y / N If so, dry eye therapy may be necessary prior to surgery to ensure a healthy ocular surface for optimal refractive outcome. TEAR HERE i. Does the patient use a SYSTANE product or other dry eye treatment? Y / N ii. Does the patient use redness reducing drops, allergy treatments or other medications that may induce dry eye? iii. Does the patient complain of itchy, red or watery eyes? iv. Is the patient a woman over 50? Possible hormone changes in women over 50 can induce dry eye. Y / N Y / N Y / N 7. Does the patient seem to have reasonable expectations? Y / N i. Does the patient s general demeanor suggest adaptability? Y / N ii. Does the staff believe, based on their observations, that the patient is adaptive? Y / N iii. Is the patient generally alert and able to understand a basic discussion of risks and benefits? Y / N 8. Is any other ocular pathology present? Y / N 3
Focused Patient Selection Candidacy Evaluation & Lens Choice Use this decision tree in conjunction with the patient s lifestyle questionnaire, biometry assessment and candidacy evaluation form to help determine whether the patient is a candidate for ATIOL implantation and which lens might best suit their unique needs. START: PATIENT PATHOLOGY Does the patient suffer from astigmatism? Is astigmatism manageable to less than 0.5 D post-op? CHOOSE TO RECOMMEND AcrySof IQ Toric IOL Does the patient have any ocular conditions, such as AMD, glaucoma or amblyopia? Treatment may be necessary before evaluating further. Does the patient display corneal irregularities, eye trauma or evidence of previous refractive surgery? Further evaluation may be necessary before candidacy can be determined. PATIENT PERSONALITY: Does the patient seem to have reasonable expectations? An AcrySof IQ monofocal lens may be the best fit for your patient. Does the patient express desire for decreased spectacle dependence? Does the patient s lifestyle include at least one near or one intermediate, in addition to one distance activity? * CHOOSE TO RECOMMEND AcrySof IQ ReSTOR +3.0 D IOL *Examples of patient activities from the sample questionnaire: Near: Reading books/newspapers, reading medicine labels, looking at your watch, viewing/dialing cell phone, knitting or needlepoint Intermediate: Applying makeup, shaving your face, card or table games, using a computer, using handheld tablet device Distance: Watching live sports, playing sports, watching TV, driving MULTIFOCAL Pre-op Phase: Informed Recommendation Knowledgeable Lens Choice AcrySof IQ ReSTOR IOL Delivers More The AcrySof IQ ReSTOR +3.0 D IOL offers true performance at all distances for the broadest range of vision. 1 AcrySof IQ Toric for patients with astigmatism The AcrySof IQ Toric IOL is the best solution for treating astigmatism at the time of surgery. The assurance of a trusted platform: 1 AcrySof IQ IOLs provide the proven benefits of excellent biomechanics, optimal biomaterials, advanced optics, ease of implantation and trusted leadership. 1 4
Focused Patient Selection Lifestyle Assessment Consider using a questionnaire like the sample below to determine patient vision preferences. Sample patient lifestyle questionnaire (to be completed by patient and placed in patient record) NOTE: Activities in the form below are grouped by near (column 1), intermediate (column 2) and distant (column 3) vision requirement from left to right, respectively Lifestyle Questionnaire Name: Date: / / Sample Form It is important to make sure your doctor has a complete understanding of your vision needs. This questionnaire will help us recommend treatment options best suited to your unique lifestyle and preferences. What is your occupation? What hobbies, sports or other recreational activities do you enjoy? TEAR HERE Please circle the activities you would prefer to do with less dependence on glasses: Reading books/newspapers Applying makeup Watching live sports Reading medicine labels Shaving your face Playing sports, like golf Looking at your watch Card or table games Watching TV Viewing/dialing cell phone Using a computer Daytime driving Knitting or needlepoint Using a handheld tablet device Nighttime driving Other activities not listed here: Please share anything else you think might be important about your lifestyle or daily activities: Patient Signature: Staff initials: Physician initials: 5
Informed Recommendation Dialogue Strategies Top line conversation points After you have determined which AcrySof IQ IOL to recommend, it is important to recommend with confidence. Touch on some key talking points with your patient, and be prepared to respond reassuringly to frequently asked questions. Recommend with confidence: Based on the thorough and revealing assessment process, I strongly recommend an advanced technology IOL as the best possible option for correcting your vision, satisfying your vision goals and meeting your quality of life needs. Clarify the recommendation: Multifocal IOLs offer a greater range of visual acuity across a broader range of distances than monofocal lenses. (or) Toric IOLs are the best solution for astigmatism treatment at the time of surgery. Address surgical concerns: Cataract surgery is one of the most common procedures in the world. I have extensive experience performing this type of surgery on a regular basis. Hundreds of thousands of these procedures have been successfully performed all over the world, and I have implanted a number of advanced technology IOLs personally. Address fear-based waiting: Cataracts are an age-related condition that eventually affects all humans. It is a medical need that should be addressed as early as possible. In addition, patient satisfaction with multifocal lens implantation is very high, with over 93% of patients surveyed saying they would have the same lens implanted again. 1 Address cost concerns: Advanced technology IOLs should be seen as a single, long-term quality of life investment. In fact, over 92% of previous cataract patients surveyed indicated they would have taken advantage of technology that could have helped reduce their need for glasses for about $2,000 per eye. 2 Support the recommendation (applies to multifocal only): IOL will ever be as perfect as your natural lens, but multifocal IOLs can get very close. I would be confident to recommend this lens to my family members, and, if I were in your shoes, I would choose a multifocal lens for myself. MULTIFOCAL Pre-op Phase: Effective Patient Education Setting and managing realistic patient expectations is key. Before asking patients to initial and date the acknowledgement form below, carefully explain the information presented. Your Alcon sales representative can provide additional patient education materials at your request. TEAR HERE AcrySof IQ ReSTOR +3.0 D IOL information acknowledgement form (to be completed by patient, copied so the patient can take a copy home and placed in patient record) AcrySof IQ ReSTOR +3.0 D IOL Information Acknowledgement Please carefully read the information below, and discuss it with your doctor. If you have any questions, be sure to get clarification before initialing and dating this form to acknowledge your understanding of the information provided. (patient name here) Sample Form I,, hereby acknowledge that I fully understand the following information with regard to the implantation of a multifocal intraocular lens: Best vision is achieved following implantation in the second eye Postoperative visual disturbances such as glare and halos are a possibility, though mild and moderate disturbances usually improve over time 1 I understand that my best reading vision will be achieved with ample lighting After surgery, there is still a chance I may occasionally need to use glasses 6 Patient initials: Date: / / 1. Alcon Lens Bench Data TDOC-0012934
MULTIFOCAL Intra-op Phase: Implantation Surgical Pearls Procedural details and areas of focus When implanting ATIOLs, be sure to consider the following: Factors for Exclusion During Surgery: Poor zonular support (implantation of a monofocal IOL may be appropriate) Mechanical or surgical manipulation or trauma required to enlarge the pupil Significant vitreous loss Significant anterior chamber bleeding Uncontrollable positive intraocular pressure (IOP) Complications in which the stability of the IOL could be compromised - Zonular damage - Capsulorhexis tear/rupture - Capsular rupture Capsulorhexis: For single-piece IOLs, the capsulorhexis should be as perfectly round and centered as possible It should also be smaller than 6.0 mm optic (typically 5.5 mm or less) Cortical Cleanup: Be thorough out to the capsule perimeter Polish the capsule Remove as many cortical cells as possible Include anterior leaflet Implantation: Capsulorhexis should overlap the optic Thorough viscoelastic removal helps avoid high post-op IOP, which can impact VA during post-op measurements Center lens in the bag Seat the lens against the capsular bag Tips for AcrySof IQ IOL Implantation: Use Purkinje image to align the IOL with the visual axis (angle kappa) - Visual access marker usage is optional Care should be taken to achieve IOL centration, as lens decentration may result in a patient experiencing visual disturbances under certain lighting conditions If the capsule is compromised during the procedure, use the MN6AD1 lens and the appropriate diopter power change if necessary Toric Pearls: Target the lowest possible residual astigmatism - Patients with significant post-op astigmatism (>0.5 D) may not achieve optimal visual outcomes Automated keratometry and temporal incisions are recommended The most favored manner in which to mark the eye is to do so at 3, 6 and 9 o clock while patient is in an upright position - Alternatively, marks at both 6 and 12 o clock are favored by some surgeons 7
MULTIFOCAL Post-op Phase: Evaluation Detailed Analysis Areas of insight After implantation, be aware of the following: 1. Have both eyes been implanted? a. If so, was the same technology used in both eyes? b. After the second eye is implanted, patients often gain an additional line of acuity when viewing with both eyes c. Binocular fusion, neural adaptation and summation typically result after the second eye is implanted 2. Fill out the post-op refractive measurements on the biometry info sheet. a. Were targets met? b. Has astigmatism been managed to <0.5 D? 3. Is acuity less than expected? a. If so, check for refractive error, dry eye, CME and posterior capsule opacification (PCO)/wrinkling b. Mild levels of PCO can result in significant loss of acuity, especially for near vision i. Posterior capsulotomy should not be performed until it is determined that other causes of acuity loss are not present ii. Most patients undergoing capsulotomy have achieved satisfactory results that became compromised when PCO developed NOTES: 8
Alcon is committed to being your trusted partner through the entire ATIOL implantation process, from patient selection to outcome evaluation. We are here to help give you the confidence to recommend the lenses that best suit your patients needs, as well as implant those lenses as effectively as possible. To order form refills for this guide or learn more about the AcrySof IQ Toric and AcrySof IQ ReSTOR +3.0 D IOLs from Alcon, call your local representative. AcrySof IQ Intraocular Lenses Physician Brief Statement CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician. INDICATIONS: The AcrySof IQ posterior chamber intraocular lens is intended for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. This lens is intended for placement in the capsular bag. WARNING/PRECAUTION: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/ benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Caution should be used prior to lens encapsulation to avoid lens decentrations or dislocations. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof Natural IOL and normal color vision. The effect on vision of the AcrySof Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45 C; use only sterile irrigating solutions such as BSS or BSS PLUS Sterile Intraocular Irrigating Solutions. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. AcrySof IQ Toric Intraocular Lenses Physician Brief Statement CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician. INDICATIONS: The AcrySof IQ Toric posterior chamber intraocular lenses are intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision. WARNING/PRECAUTION: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/ benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Toric IOLs should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens encapsulation. All viscoelastics should be removed from both the anterior and posterior sides of the lens; residual viscoelastics may allow the lens to rotate. Optical theory suggest, that, high astigmatic patients (i.e. > 2.5 D) may experience spatial distortions. Possible toric IOL related factors may include residual cylindrical error or axis misalignments. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof IQ Toric Cylinder Power IOLs. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof Natural IOL and normal color vision. The effect on vision of the AcrySof Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45 C; use only sterile irrigating solutions such as BSS or BSS PLUS Sterile Intraocular Irrigating Solutions. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. AcrySof IQ ReSTOR Intraocular Lenses Physician Brief Statement CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician. INDICATIONS: The AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag. WARNING/PRECAUTION: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Physicians should target emmetropia, and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye at the close of surgery. Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. Clinical studies with the AcrySof ReSTOR lens indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically significant PCO. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof IQ ReSTOR IOLs. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof Natural IOL and normal color vision. The effect on vision of the AcrySof Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45 C; use only sterile irrigating solutions such as BSS or BSS PLUS Sterile Intraocular Irrigating Solutions. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. LENSTAR LS 900 Optical Biometer Indications for Use CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician. The LENSTAR LS 900 Biometer is a non-invasive, non-contact OLCR (Optical Low Coherence Reflectometry) Biometer used for obtaining ocular measurements and performing calculations to assist in the determination of the appropriate power and type of IOL (intraocular lens) for implantation after removal of the natural crystalline lens following cataract removal. The LENSTAR LS 900 Biometer measures: Axial eye length Corneal thickness Anterior chamber depth Lens thickness Radii of curvature of flat and steep meridian Axis of the flat meridian White to white distance Pupil diameter 2012 vartis 7/12 RES12180SA AlconSurgical.com LENSTAR is a registered trademark of Haag-Streit. 1. AcrySof IQ ReSTOR IOL. Directions for Use. 2. Chase Health Advance Financing Options Survey; Chasehealthadvance.com. 3. AcrySof IQ ReSTOR IOL data on file.