Laser-Assisted Cataract Surgery
From a clinical perspective, with any new technology, there is a learning curve, which could initially lead to increased risk for complications. The learning curve may have been more of an issue for surgeons not familiar with the use and limitations of the FSL. The learning curve could also be different between the different systems available. Some of the mastered techniques of cataract surgery, for example, such as hydrodissection and chopping or 'dividing and conquering', may have to be revisited. Because the laser is creating gas in the lens and capsular bag during fragmentation, gas bubbles may build up in the subcapsular space and increase pressure in the bag. The bubbles can also pose an optical issue. Cortical removal may also vary as the cortical tags typically seen with manual surgery are often not present after a FSL treatment. New techniques may need to be tried and mastered for these typical routine cases. General increased surgeon awareness, improved training techniques, and improvements with the software have contributed to flattening of the learning curve. Additionally, the learning curve is generally short and once overcome, the safety outcomes are likely comparable, if not better, than manual cataract surgery.
There are certain eye conditions and categories of cataracts that may pose increased challenges or that simply may not be able to be treated with the FSL, including white cataracts, dense corneal scars and edema, or small pupil cases because of poor dilation or intraoperative floppy iris syndrome (IFIS). This is because of the laser's inability to treat through opaque tissues. Small pupil or IFIS cases could be treated on a case-by-case basis and may require the use of intracameral epinephrine or a Malyugin ring prior to the laser procedure (Fig. 9).
(Enlarge Image)
Figure 9.
Use of Malyugin ring for IFIS with FSL. FSL, femtosecond laser; IFIS, intraoperative floppy iris syndrome.
There is also a subset of patients who are not candidates for the laser, and these individuals need to be identified and screened carefully prior to surgery. Given the anatomy and location of the suction device during the treatment, a patient with severe conjunctival chalasis, a small orbit, a functioning bleb, tube, or valve would not be able to be treated. Additionally, patients who are unable to position for the FSL or those with history of severe glaucoma are not good candidates as the FSL can cause mild to significant IOP rise, depending on the model. Table 1 summarizes the risk factors for unsuccessful docking and laser treatment as a flow chart. A cosmetic disadvantage of the laser is the incidence of subconjunctival hemorrhage because of the required use of the suction ring for the FSL treatment. Although this is self-limited, it is not ideal.
Certain patient groups that may specifically benefit from the FSL include patients with potential weak zonules such as eyes with pseudoexfoliation or posttrauma. The FSL may also have a special role for patients with nonopacified Fuchs' endothelial dystrophy corneas as lower EPT could potentially be used, preserving the endothelial cells. Although these types of eyes may have significant advantages from a therapeutic standpoint, according to the Center of Medicare and Medicaid Services (CMS), the use of laser will not be covered by insurance for these therapeutic reasons alone. Surgeons are only authorized to charge patients for the use of FSL when treating astigmatism or in conjunction with the use of presbyopic or toric intraocular lenses.
Incorporating new technologies into practice requires both business and marketing considerations. The laser and its ongoing use require significant cost to the entity purchasing the unit as well as to the patient undergoing this noninsurance-covered service. Practices, surgical centers, and hospitals will therefore need to evaluate their surgical volumes as well as the patient's demand for the technology. Surgeons will need to attempt to identify the appropriate patient populations who will benefit, are medically able, and demonstrate willingness to pay for the procedure. Other cost considerations include training of staff and increased time required counseling patients about the technology. Surgical coordinators will need to be educated on the different options and provide information and guidance to patients. Sufficient time will have to be allotted for cataract evaluations preoperatively as additional time is involved with reviewing options with patients. Operating room time considerations will also need to be adjusted for which will likely affect the number of patients who can have surgery on a given day. For this reason, patients may experience an increased wait time to have their procedure scheduled if surgeons are forced to reduce the number of cases performed during their operating room block time. Marketing will be critical, so patients are aware and can access this new technology. Practices will need to find ways to market and advertise. This will also require significant time, cost, and office resources.
Another consideration for the purchase includes the additional space required to use the unit. The decision will need to be made where it will be placed, either within or outside the operating room. The patient could have the laser done in the same operating room as the cataract removal. Other alternatives include placing it in its own operating room or in the preoperative or postoperative area. There are significant workflow considerations that must be addressed as well and will be dependent on the location of the FSL. The most efficient way of incorporating the FSL may not be obvious and there is more than one way to approach this issue; the FSL portion could be performed first in the same operating room, followed by the cataract removal. Alternatively, the FSL portion could be performed in an independent area or operating room, and then the surgeon could operate on another laser patient or do a manual surgery while the recently lasered patient is getting set up to have the cataract removal. Ideally, the operating room and laser location should be close to one another to limit transport time. There will also have to be additional personal to handle the transports. It will be critical to maximize the efficiency for both the surgeon and the operating room personal and space, so that there is little to no 'downtime' and waiting between procedures. Careful planning will be required.
There is also additional operating room time per case involved with the use of laser. Although the laser treatment itself is typically only a few minutes, there is time involved with getting the patient positioned under the laser as well as associated OCT imaging and treating the eye. The phacoemulsification portion of the procedure is done at the operating microscope so the patient will have to move from either the laser bed or be wheeled out from under the laser to the operating microscope. These logistical issues as well as the other previously mentioned issues could result in increased time spent with each individual patient. This overall increased time could influence the volume of cataract patients that a surgeon, surgical center, or hospital may be able to perform during a given operating room block if not evaluated carefully. All of these considerations must be taken into account when practices are determining the patient charges that should be associated with the procedure.
Barriers of the Femtosecond Laser
From a clinical perspective, with any new technology, there is a learning curve, which could initially lead to increased risk for complications. The learning curve may have been more of an issue for surgeons not familiar with the use and limitations of the FSL. The learning curve could also be different between the different systems available. Some of the mastered techniques of cataract surgery, for example, such as hydrodissection and chopping or 'dividing and conquering', may have to be revisited. Because the laser is creating gas in the lens and capsular bag during fragmentation, gas bubbles may build up in the subcapsular space and increase pressure in the bag. The bubbles can also pose an optical issue. Cortical removal may also vary as the cortical tags typically seen with manual surgery are often not present after a FSL treatment. New techniques may need to be tried and mastered for these typical routine cases. General increased surgeon awareness, improved training techniques, and improvements with the software have contributed to flattening of the learning curve. Additionally, the learning curve is generally short and once overcome, the safety outcomes are likely comparable, if not better, than manual cataract surgery.
There are certain eye conditions and categories of cataracts that may pose increased challenges or that simply may not be able to be treated with the FSL, including white cataracts, dense corneal scars and edema, or small pupil cases because of poor dilation or intraoperative floppy iris syndrome (IFIS). This is because of the laser's inability to treat through opaque tissues. Small pupil or IFIS cases could be treated on a case-by-case basis and may require the use of intracameral epinephrine or a Malyugin ring prior to the laser procedure (Fig. 9).
(Enlarge Image)
Figure 9.
Use of Malyugin ring for IFIS with FSL. FSL, femtosecond laser; IFIS, intraoperative floppy iris syndrome.
There is also a subset of patients who are not candidates for the laser, and these individuals need to be identified and screened carefully prior to surgery. Given the anatomy and location of the suction device during the treatment, a patient with severe conjunctival chalasis, a small orbit, a functioning bleb, tube, or valve would not be able to be treated. Additionally, patients who are unable to position for the FSL or those with history of severe glaucoma are not good candidates as the FSL can cause mild to significant IOP rise, depending on the model. Table 1 summarizes the risk factors for unsuccessful docking and laser treatment as a flow chart. A cosmetic disadvantage of the laser is the incidence of subconjunctival hemorrhage because of the required use of the suction ring for the FSL treatment. Although this is self-limited, it is not ideal.
Certain patient groups that may specifically benefit from the FSL include patients with potential weak zonules such as eyes with pseudoexfoliation or posttrauma. The FSL may also have a special role for patients with nonopacified Fuchs' endothelial dystrophy corneas as lower EPT could potentially be used, preserving the endothelial cells. Although these types of eyes may have significant advantages from a therapeutic standpoint, according to the Center of Medicare and Medicaid Services (CMS), the use of laser will not be covered by insurance for these therapeutic reasons alone. Surgeons are only authorized to charge patients for the use of FSL when treating astigmatism or in conjunction with the use of presbyopic or toric intraocular lenses.
Incorporating new technologies into practice requires both business and marketing considerations. The laser and its ongoing use require significant cost to the entity purchasing the unit as well as to the patient undergoing this noninsurance-covered service. Practices, surgical centers, and hospitals will therefore need to evaluate their surgical volumes as well as the patient's demand for the technology. Surgeons will need to attempt to identify the appropriate patient populations who will benefit, are medically able, and demonstrate willingness to pay for the procedure. Other cost considerations include training of staff and increased time required counseling patients about the technology. Surgical coordinators will need to be educated on the different options and provide information and guidance to patients. Sufficient time will have to be allotted for cataract evaluations preoperatively as additional time is involved with reviewing options with patients. Operating room time considerations will also need to be adjusted for which will likely affect the number of patients who can have surgery on a given day. For this reason, patients may experience an increased wait time to have their procedure scheduled if surgeons are forced to reduce the number of cases performed during their operating room block time. Marketing will be critical, so patients are aware and can access this new technology. Practices will need to find ways to market and advertise. This will also require significant time, cost, and office resources.
Another consideration for the purchase includes the additional space required to use the unit. The decision will need to be made where it will be placed, either within or outside the operating room. The patient could have the laser done in the same operating room as the cataract removal. Other alternatives include placing it in its own operating room or in the preoperative or postoperative area. There are significant workflow considerations that must be addressed as well and will be dependent on the location of the FSL. The most efficient way of incorporating the FSL may not be obvious and there is more than one way to approach this issue; the FSL portion could be performed first in the same operating room, followed by the cataract removal. Alternatively, the FSL portion could be performed in an independent area or operating room, and then the surgeon could operate on another laser patient or do a manual surgery while the recently lasered patient is getting set up to have the cataract removal. Ideally, the operating room and laser location should be close to one another to limit transport time. There will also have to be additional personal to handle the transports. It will be critical to maximize the efficiency for both the surgeon and the operating room personal and space, so that there is little to no 'downtime' and waiting between procedures. Careful planning will be required.
There is also additional operating room time per case involved with the use of laser. Although the laser treatment itself is typically only a few minutes, there is time involved with getting the patient positioned under the laser as well as associated OCT imaging and treating the eye. The phacoemulsification portion of the procedure is done at the operating microscope so the patient will have to move from either the laser bed or be wheeled out from under the laser to the operating microscope. These logistical issues as well as the other previously mentioned issues could result in increased time spent with each individual patient. This overall increased time could influence the volume of cataract patients that a surgeon, surgical center, or hospital may be able to perform during a given operating room block if not evaluated carefully. All of these considerations must be taken into account when practices are determining the patient charges that should be associated with the procedure.