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Marlene, AcrySof® IQ Toric IOL patient

Marlene, AcrySof® IQ Toric IOL patient

I think you become accepting of what you're seeing, and you don't really know what the opportunities are.

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Cataracts and
Other Eye Diseases

Confusion is common when it comes to cataracts and whether other eye conditions or diseases contribute to their formation or not. Here is a breakdown of the facts:

  • If you have diabetes, you are at a greater risk for developing cataracts. This is because the eye's lens   Lens: The transparent disc behind the pupil that brings light into focus on the retina.   can become over-hydrated as deposits form at the front or back of the lens. In some cases, this type of cataract can develop within days and should be taken seriously, since more Americans between the ages of 20 and 74 go blind from diabetes complications than any other disease. For tips on preventing diabetes, go here.
  • Age-related macular degeneration   Age-related macular degeneration (AMD): The leading cause of vision loss and legal blindness in adults over age 60, AMD affects the sharp, straight-forward vision necessary for reading, driving, and other daily activities. It is an eye disease that impacts the macula (the centermost part of the retina responsible for seeing fine detail) and occurs in 2 forms, dry AMD and wet AMD, with wet AMD being the more serious form.   (AMD) does not cause cataracts, nor vice-versa, but if you suffer from both, your doctor may recommend surgery to treat the damaged retina or back of the eye followed by cataract surgery to remove the cataract and replace with an artificial lens. AMD is the leading cause of vision loss and legal blindness in American adults over 60 and occurs when the center of the retina begins to degenerate.
  • Because they are both age-related, presbyopia and cataracts can occur simultaneously, but neither one causes the other.
  • Astigmatism, a common refractive error that can cause blurred vision near or far, doesn't lead to cataracts but can be treated during cataract surgery with a special lens called the AcrySof® IQ Toric IOL. Read more here.
  • Cataracts can sometimes cause refractive errors, such as   Refractive errors: Vision problems caused by an imperfect optical system, most commonly myopia, hyperopia, and astigmatism.   nearsightedness or farsightedness, and rarely, if left to mature, a cataract can even become so large that it triggers a type of glaucoma, a condition in which the eye has difficulty draining. Glaucoma does not cause cataracts and typically, cataracts do not lead to glaucoma, except in rare cases, such as in the result of eye trauma or steroid use.

Myopia—The eyeball is elongated or the cornea is more convex or the lens is thicker causing the focused image to fall short of the retina.

Hyperopia—The eyeball is shorter or the cornea is flat causing the focused image to fall “behind” the retina.

Astigmatism—The focus of the lens and cornea produces a partially focused image both in front of and behind the retina, resulting in a blurred image at the retina.

Presbyopia—The lens becomes less flexible causing the image from a near object to fall “behind” the retina, blurring it.

Find out how cutting-edge advancements in cataract treatments, such as AcrySof® IQ ReSTOR® IOL and AcrySof® IQ Toric IOL, may be able to help you see better after cataract surgery and may even rid you of eyeglasses and contact lenses.

Read the Product Information (Brief Statement of Intended Use)

OptiLASIK® Laser Vision Correction

Myopia:

  • Approval of the premarket approval application is for the WaveLight® ALLEGRETTO WAVE®/ ALLEGRETTO WAVE® Eye-Q Excimer Laser System to perform LASIK treatments in patients 18 years of age or older for the reduction or elimination of myopic refractive errors up to -12.0 diopters (D) of sphere with and without astigmatic refractive errors up to -6.0 D; and in patients with documented evidence of a stable manifest refraction defined as less than or equal to 0.50 D of preoperative spherical equivalent shift over one year prior to surgery.
  • LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries.
  • Approval of the application is based on clinical trials in the United States with 901 eyes treated, of which 813 of 866 eligible eyes were followed for 12 months. Accountability at 3 months was 93.8%, at 6 months was 91.9%, and at 12 months was 93.9%.
  • The studies found that of the 844 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 3-month stability time point, 98.0% were corrected to 20/40 or better, and 84.4% were corrected to 20/20 or better without spectacles or contact lenses.
  • The clinical trials showed that the following subjective patient adverse events were reported as "moderate to severe" at a level at least 1% higher than baseline of the subjects at 3 months posttreatment: visual fluctuations (12.8% at baseline versus 28.6% at 3 months).
  • Long-term risks of LASIK for myopia with and without astigmatism beyond 12 months have not been studied.
  • Note that the complete name for this ophthalmic laser is "WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System for laser assisted in-situ keratomileusis (LASIK) treatments of myopic refractive errors up to -12.0 diopters (D) of sphere with and without astigmatic refractive errors up to -6.0 D at the spectacle plane."

Hyperopia:

  • Approval of the premarket approval application is for the WaveLight® ALLEGRETTO WAVE®/ ALLEGRETTO WAVE® Eye-Q Excimer Laser System to perform LASIK treatments in patients 18 years of age or older for the reduction or elimination of hyperopic refractive errors up to +6.0 diopters (D) of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D; and in patients with documented evidence of a stable manifest refraction defined as less than or equal to 0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia.
  • LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries.
  • Approval of the application is based on clinical trials in the United States with 290 eyes treated, of which 100 of 290 eligible eyes were followed for 12 months. Accountability at 3 months was 95.2%, at 6 months was 93.9%, and at 12 months was 69.9%.
  • The studies found that of the 212 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 6-month stability time point, 95.3% were corrected to 20/40 or better, and 67.5% were corrected to 20/20 or better without spectacles or contact lenses.
  • The study showed that the following subjective patient adverse events were reported as "much worse" by at least 1% of the subjects (in order of increasing frequency) at 6 months post final treatment: glare from bright lights (3.0%); night driving glare (4.2%) light sensitivity (4.9%); visual fluctuations (6.1%); and halos (6.4%).
  • Long term risks of LASIK for hyperopia with and without astigmatism beyond 12 months have not been studied.
  • Note that the complete name for this ophthalmic laser is "WaveLight® ALLEGRETTO WAVE®/ ALLEGRETTO WAVE® Eye—Q Excimer Laser System for laser assisted in-situ keratomileusis (LASIK) treatments of hyperopic refractive errors up to +6.0 diopters (D) of sphere with and without astigmatic refractive errors up to 5.0 D with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D."

Mixed Astigmatism:

  • Approval of the premarket approval application is for the WaveLight® ALLEGRETTO WAVE®/ ALLEGRETTO WAVE® Eye-Q Excimer Laser System to perform LASIK treatments in patients 21 years of age or older for the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 D at the spectacle plane; and in patients with documentation of a stable manifest refraction defined as less than or equal to 0.50 D of preoperative spherical equivalent shift over one year prior to surgery.
  • LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries.
  • Approval of the application is based on clinical trials in the United States with 162 eyes treated, of which 111 were eligible to be followed at 6 months. Accountability at 1 month was 99.4%, at 3 months was 96.0%, and at 6 months was 100.0%.
  • The studies found that of the 142 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 3-month stability time point, 95.8% achieved acuity of 20/40 or better, and 67.6% achieved acuity of 20/20 or better without spectacles or contact lenses.
  • The clinical trials showed that the following subjective patient adverse events were reported as "moderate to severe" at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: sensitivity to light (43.3% at baseline versus 52.9% at 3 months); visual fluctuations (32.1% at baseline versus 43.0% at 3 months); and halos (37.0% at baseline versus 42.3% at 3 months).
  • Long term risks of LASIK for mixed astigmatism beyond 6 months have not been studied.
  • The safety and effectiveness of LASIK surgery has ONLY been established with an optical zone of 6.0 - 7.0 mm and an ablation zone of 9.0 mm.
  • Note that the complete name for this ophthalmic laser is "WaveLight® ALLEGRETTO WAVE®/ ALLEGRETTO WAVE® Eye-Q Excimer Laser System for laser assisted in-situ keratomileusis (LASIK) treatments of naturally occurring mixed astigmatism of up to 6.00 D at the spectacle plane."

Wavefront-Guided Treatment of Myopia:

  • Approval of the premarket approval application is for the WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System used in conjunction with the WaveLight® Analyzer device. The device uses a 6.5 mm optical zone, a 9.0 mm ablation/treatment zone, and is indicated for wavefront-guided (WFG) laser assisted in-situ keratomileusis (LASIK):
    1) for the reduction or elimination of up to -7.00 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -7.00 D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane;
    2) in patients who are 18 years of age or older; and
    3) in patients with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical equivalent shift over one year prior to surgery.
  • LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), traditional LASIK and other refractive surgeries.
  • Approval of the application is based on a randomized clinical trial in the United States with 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized®LASIK (Control Cohort). 178 of the Study Cohort and 180 of the Control Cohort were eligible to be followed at 6 months. In the Study Cohort, accountability at 1 month was 96.8%, at 3 months was 96.8%, and at 6 months was 93.3%. In the Control Cohort, accountability at 1 month was 94.6%, at 3 months was 94.6%, and at 6 months was 92.2%.
  • The studies found that of the 180 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 6-month stability time point in the Study Cohort, 99.4% were corrected to 20/40 or better, and 93.4% were corrected to 20/20 or better without spectacles or contact lenses. In the Control Cohort, of the 176 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 6-month stability time point, 99.4% were corrected to 20/40 or better, and 92.8% were corrected to 20/20 or better without spectacles or contact lenses.
  • The clinical trials showed that the following subjective patient adverse events were reported as "moderate to severe" at a level at least 1% higher than baseline of the subjects at 3 months post-treatment in the Study Cohort, light sensitivity (37.2% at baseline versus 47.8% at 3 months) and visual fluctuations (13.8% at baseline versus 20.0% at 3 months). In the Control Cohort, halos (36.6% at baseline versus 45.4% at 3 months) and visual fluctuations (18.3% at baseline versus 21.9% at 3 months).
  • Long term risks of wavefront-guided LASIK for myopia with and without astigmatism beyond 6 months have not been studied.
  • Note that the complete name for this ophthalmic laser is "WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System used in conjunction with the WaveLight® Analyzer device. The device uses a 6.5 mm optical zone, a 9.0 mm ablation/treatment zone, and is indicated for wavefront-guided (WFG) laser-assisted in-situ keratomileusis (LASIK): 1) for the reduction or elimination of up to -7.00 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -7.00 D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane; 2) in patients who are 18 years of age or older; and 3) in patients with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical equivalent shift over one year prior to surgery."

 

AcrySof® IQ ReSTOR® IOL

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

INDICATIONS: The AcrySof® IQ ReSTOR® Apodized Diffractive Optic 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.

WARNINGS: 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 Physician Labeling. Some adverse reactions that have been associated with the implantation of intraocular lenses are: hypopyon, intraocular infection, acute corneal decompensation, macular edema, pupillary block, retinal detachment, and secondary surgical intervention (including but not limited to lens repositioning, biometry error, visual disturbances or patient dissatisfaction). As a result of the multifocality, some visual effects (halos or radial lines around point sources of light at night) may also be expected due to the superposition of focused and unfocused multiple images. A reduction in contrast sensitivity may also be experienced by some patients, especially in low lighting conditions such as driving at night. In order to achieve optimal visual performance with this lens, emmetropia must be targeted. Patients with significant preoperative or expected postoperative astigmatism >1.0D may not achieve optimal visual outcomes. Care should be taken to achieve IOL centration, as lens decentration may result in a patient experiencing visual disturbances under certain lighting conditions.

PRECAUTIONS: Do not resterilize. Do not store over 45° C. Use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solution. Clinical studies with the AcrySof® ReSTOR® IOL indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically significant PCO. 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. The long-term effects of filtering blue light and the clinical efficacy of that filtering on the retina have not been conclusively established.

ATTENTION: Reference the Physician Labeling/Directions for Use for a complete listing of indications, warnings and precautions.

AcrySof® IQ Toric IOL

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

INDICATIONS: AcrySof® IQ Toric IOL Models SN6AT3, SN6AT4, and SN6AT5 Posterior Chamber Intraocular lenses are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia and pre-existing corneal astigmatism secondary to the 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.

WARNINGS: 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.

PRECAUTIONS: 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.

LenSx® Laser Refractive Cataract Surgery

Caution Concerning Forward-Looking Statements. This press release may contain forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995.Any forward-looking statements reflect the views of our management as of the date of this press release with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except to the extent required under the federal securities laws and the rules and regulations promulgated by the Securities and Exchange Commission, we undertake no obligation to publicly update or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.