As one of the optometrists in a two-MD, three-OD medical practice, Jessica Schiffbauer, OD, MBA, FAAO, plays a pivotal role in guiding patients through their cataract surgery journey. Many patients at The Eye Centers of Racine and Kenosha in Wisconsin catch her enthusiasm for the new technology in Light Adjustable Lens™ (LAL™ /LAL+®) from RxSight®. The Light Adjustable Lens is a premium intraocular lens (IOL) that is customized after cataract surgery.
Unlike traditional IOLs, where the surgeon selects a lens power before surgery, eye care professionals like Dr. Schiffbauer can adjust Light Adjustable Lens. Each adjustment is precisely delivered through a UV light treatment using the Light Delivery Device™ (LDD™), correcting residual refractive error and allowing doctors to optimize vision to their patients’ lifestyles.
That adjustability is what sets the Light Adjustable Lens apart, as Dr. Schiffbauer explains to patients. “It’s incredible to offer patients the chance to truly ‘test-drive’ their vision,” she says. “They can customize their post-surgery vision based on their specific goals and lifestyle, something we couldn’t do before with traditional lens implants.” In her collaborative role, she helps patients understand the range of options available and how the Light Adjustable Lens can be fine-tuned to their needs.
POST-OP PROCESS
The Light Adjustable Lens requires additional follow-ups for these adjustments, a point that Dr. Schiffbauer emphasizes regularly. Patients come in for their routine one-day and one-week postoperative visits. Once the healing is complete and the eye is stable, she will begin the light adjustments.
“Patients are usually thrilled—they feel like they have a say in how they want their vision to be corrected. The follow-up treatments may take some time, but the results are worth it.” One recent patient’s feedback highlighted the success of this approach. “They said it was awesome to be part of the decision-making process—seeing how their vision changed and being able to adjust it.”
There is a minimum of one adjustment session and patients can have as many as three. At each of these, the LDD emits a pattern of UV light that polymerizes the macromers in the lens within the path of the light. This process helps to precisely change the shape of the lens, resulting in a power change. Once the patient achieves their optimal vision, the final exposure polymerizes all remaining macromers and locks them in place, preventing any further changes to the lens and ensuring a truly customized result.
For Dr. Schiffbauer, that patient-centric approach is a key reason why optometrists who see any cataract patients should familiarize themselves with this evolving technology. These optometrists play a key role in the IOL recommendation process. “When I see a patient, I talk to them about their goals—whether they have a specific vision demand or want to improve their distance vision. That helps set expectations, especially when it comes to the customizable nature of the Light Adjustable Lens,” she explains. “Optometrists who are not in a collaborative care setting with surgeons can take the same approach,” she says.
FOSTERING RELATIONSHIPS
Dr. Schiffbauer continues, “Patients often trust their optometrists more because we’ve built rapport with them over the years. Patients will see the surgeon only a few times. So, if you’re referring a patient for cataract surgery, it’s important to be involved in their journey beyond just the referral.” Plus, a patient’s optometrist is also often the one who understands the nuances of the patient’s journey. Knowing that a patient had a hard time adjusting to contact lenses focused at different distances would be helpful to know in setting expectations. That patient might be counseled that achieving excellent distance vision is the goal and the patient may need to rely on readers for fine print or could need to ensure that their near-work environment is well-lit, for example.
By fostering relationships with cataract surgeons and staying updated on IOL options, especially with the Light Adjustable Lens, optometrists can build even stronger relationships with providers and greater trust with patients. She encourages ODs to take the opportunity to shadow surgeons or observe post-op appointments if possible. “This helps in understanding the entire patient experience.”
Certainly, talk with the surgeon, but also talk with any optometrists in that practice who might be referring patients for the Light Adjustable Lens or handling the light adjustment, she suggests. Those conversations can help you determine how you want to present this option and information to patients. “Don’t be afraid to ask for help or guidance from your colleagues. Collaborative care is about teamwork, and ultimately, it leads to better outcomes for our patients.”
INDICATIONS FOR USE AND IMPORTANT SAFETY INFORMATION
INDICATIONS: The Light Adjustable Lens™ (LAL™) and Light Delivery Device™ (LDD™) system is indicated for the reduction of residual astigmatism to improve uncorrected visual acuity after removal of the cataractous natural lens by phacoemulsification and implantation of the intraocular lens in the capsular bag in adult patients with preexisting corneal astigmatism of ≥ 0.75 diopters and without preexisting macular disease. The system also reduces the likelihood of clinically significant residual spherical refractive errors. CONTRAINDICATIONS: The Light Adjustable Lens is contraindicated in patients who are taking systemic medication that may increase sensitivity to ultraviolet (UV) light as the LDD treatment may lead to irreversible phototoxic damage to the eye; patients who are taking a systemic medication that is considered toxic to the retina (e.g., tamoxifen) as they may be at increased risk of retinal damage during LDD treatment; patients with a history of ocular herpes simplex virus due to the potential for reactivation from exposure to UV light; patients with nystagmus as they may not be able to maintain steady fixation during LDD treatment; and patients who are unwilling to comply with the postoperative regimen for adjustment and lock-in treatments and wearing of UV protective eyewear. WARNINGS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting an IOL in a patient with any of the conditions described in the Light Adjustable Lens and LDD Professional Use Information document. Caution should be used in patients with eyes unable to dilate to a pupil diameter of ≥ 7 mm to ensure that the edge of the Light Adjustable Lens can be visualized during LDD light treatments; patients who the doctor believes will be unable to maintain steady fixation that is necessary for centration of the LDD light treatment; patients with sufficiently dense cataracts that preclude examination of the macula as patients with preexisting macular disease may be at increased risk for macular disease progression; and patients at high risk for future vitreoretinal disease that may require silicone oil as part of therapy. The Light Adjustable Lens must be implanted in the correct orientation with the back layer facing posteriorly. PRECAUTIONS: The long-term effect on vision due to exposure to UV light that causes erythropsia (after LDD treatment) has not been determined. The implanted Light Adjustable Lens MUST undergo a minimum of 2 LDD treatments (1 adjustment procedure plus 1 lock-in treatment) beginning at least 17-21 days post-implantation. All clinical study outcomes were obtained using LDD power adjustments targeted to emmetropia post LDD treatments. The safety and performance of targeting to myopic or hyperopic outcomes have not been evaluated. The safety and effectiveness of the Light Adjustable Lens and LDD have not been substantiated in patients with preexisting ocular conditions and intraoperative complications. Patients must be instructed to wear the RxSight-specified UV protective eyewear during all waking hours after Light Adjustable Lens implantation until 24 hours post final lock-in treatment. Unprotected exposure to UV light during this period can result in unpredictable changes to the Light Adjustable Lens, causing aberrated optics and blurred vision, which might necessitate explantation of the Light Adjustable Lens. ADVERSE EVENTS: The most common adverse events (AEs) reported in the randomized pivotal trial included cystoid macular edema (3 eyes, 0.7%), hypopyon (1 eye, 0.2%), and endophthalmitis (1 eye, 0.2%). The rates of AEs did not exceed the rates in the ISO historical control except for the category of secondary surgical interventions (SSI); 1.7% of eyes (7/410) in the Light Adjustable Lens group had an SSI (p < .05). AEs related to the UV light from the LDD include phototoxic retinal damage causing temporary loss of best spectacle corrected visual acuity (1 eye, 0.2%), persistent induced tritan color vision anomaly (2 eyes, 0.5%), persistent induced erythropsia (1 eye, 0.3%), reactivation of ocular herpes simplex Infection (1 eye, 0.3%), and persistent unanticipated significant increase in manifest refraction error (≥ 1.0 D cylinder or MRSE) (5 eyes, 1.3%). CAUTION: Federal law restricts this device to sale by or on the order of a physician. Please see the Professional Use Information document for a complete list of contraindications, warnings, precautions, and adverse events.
INDICATIONS: The Light Adjustable Lens+ ™ (LAL+ ® ) and Light Delivery Device ™ (LDD ™ ) system is indicated for the reduction of residual astigmatism to improve uncorrected visual acuity after removal of the cataractous natural lens by phacoemulsification and primary implantation of the intraocular lens in the capsular bag in adult patients with preexisting corneal astigmatism of ≥ 0.75 diopters and without preexisting macular disease. The system also reduces the likelihood of clinically significant residual spherical refractive errors. CONTRAINDICATIONS: The LAL+ is contraindicated in patients who are taking systemic medication that may increase sensitivity to ultraviolet (UV) light as the LDD treatment may lead to irreversible phototoxic damage to the eye; patients who are taking a systemic medication that is considered toxic to the retina (e.g., tamoxifen) as they may be at increased risk of retinal damage during LDD treatment; patients with a history of ocular herpes simplex virus due to the potential for reactivation from exposure to UV light; patients with nystagmus as they may not be able to maintain steady fixation during LDD treatment; and patients who are unwilling to comply with the postoperative regimen for adjustment and lock-in treatments and wearing of UV protective eyewear. WARNINGS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting an IOL in a patient with any of the conditions described in the LAL+ and LDD Professional Use Information document. Caution should be used in patients with eyes unable to dilate to a pupil diameter of ≥ 7 mm to ensure that the edge of the LAL+ can be visualized during LDD light treatments; patients who the doctor believes will be unable to maintain steady fixation that is necessary for centration of the LDD light treatment; patients with sufficiently dense cataracts that preclude examination of the macula as patients with preexisting macular disease may be at increased risk for macular disease progression; and patients at high risk for future vitreoretinal disease that may require silicone oil as part of therapy. The LAL+ must be implanted in the correct orientation with the back layer facing posteriorly. PRECAUTIONS: The safety and effectiveness of the LAL+ has not been substantiated in clinical trials. The effects of the LAL+ optical design on the quality of vision, contrast sensitivity, and subjective visual disturbances (glare, halo, etc.) have not been evaluated clinically. Surgeons must weigh the potential benefits of the modified optical design of the LAL+ against the potential for risks associated with degradation in vision quality and the lack of clinical data to characterize the impact of the LAL+ optical design on contrast sensitivity and subjective visual disturbance. These considerations may be especially relevant to patients with certain pre-existing ocular conditions (prior corneal refractive surgery, irregular corneal astigmatism, severe corneal dystrophy, macular disease, or optic nerve atrophy, etc.) or intraoperative conditions (posterior capsular rupture, complications in which the IOL stability could be compromised, inability to place IOL in capsular bag, etc.). The long-term effect on vision due to exposure to UV light that causes erythropsia (after LDD treatment) has not been determined. The implanted LAL+ MUST undergo a minimum of 2 LDD treatments (1 adjustment procedure plus 1 lock-in treatment) beginning at least 17-21 days post-implantation. All clinical study outcomes were obtained using LDD power adjustments targeted to emmetropia post-LDD treatments. The safety and performance of targeting to myopic or hyperopic outcomes have not been evaluated. The safety and effectiveness of the LAL+ and LDD have not been substantiated in patients with preexisting ocular conditions and intraoperative complications. Patients must be instructed to wear the RxSight-specified UV protective eyewear during all waking hours after LAL+ implantation until 24 hours post final lock-in treatment. Unprotected exposure to UV light during this period can result in unpredictable changes to the LAL+, causing aberrated optics and blurred vision, which might necessitate explantation of the LAL+. When performing refraction in patients implanted with the LAL+, confirmation of refraction with maximum plus manifest refraction technique is recommended. ADVERSE EVENTS: The most common adverse events (AEs) reported in the randomized pivotal trial of the parent LAL included cystoid macular edema (3 eyes, 0.7%), hypopyon (1 eye, 0.2%), and endophthalmitis (1 eye, 0.2%). The rates of AEs did not exceed the rates in the ISO historical control except for the category of secondary surgical interventions (SSI); 1.7% of eyes (7/410) in the LAL group had an SSI (p < .05). AEs related to the UV light from the LDD include phototoxic retinal damage causing temporary loss of best spectacle corrected visual acuity (1 eye, 0.2%), persistent induced tritan color vision anomaly (2 eyes, 0.5%), persistent induced erythropsia (1 eye, 0.3%), reactivation of ocular herpes simplex infection (1 eye, 0.3%), and persistent unanticipated significant increase in manifest refraction error (≥ 1.0 D cylinder or MRSE) (5 eyes, 1.3%). CAUTION: Federal law restricts this device to sale by or on the order of a physician. Please see the Professional Use Information document for a complete list of contraindications, warnings, precautions, and adverse events.
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