Hospital de Braga, Portugal
Crystalline lens surgery is now more than a visual acuity repair surgery because of the technological advancement that allows safe surgery, with complication rates for experienced surgeons well below 1%, predictability of calculating lenses that are implanted and their ability to correct all ametropia. Thus, lens surgery is increasingly viewed as a refractive procedure.
Extraction of the transparent crystalline lens was, at the end of the last century, reserved for major ametropias, being associated in the myopes with an increased incidence of retinal detachment1,2.
With the emergence of multifocal lenses, a paradigm shift has taken place and the clear lens extraction is beginning to be indicated in patients with ametropia-associated presbyopia3, in hyperopes from the age of fifty and in myopes from the age of fifty-five.
Today there is a plethora of multifocal (bifocal, trifocal, extended focus) and toric lenses that allow the presbyopia to be satisfactorily corrected in all patients who wish4-8 and may undergo surgery. As a consequence of this progress, patients are becoming increasingly young and with lower refractive errors. In the USA, because of the need for insurers to share surgeries and for marketing, two concepts emerged: DLS9 and PRELEX.
The DLS (Dysfunctional Lens Syndrome) was so named for the first time by George Waring IV. According to this author the patient with DLS presents cataract-like symptoms with no evidence of it.
The choice of the DLS name stems from the fact that the syndrome shows signs and symptoms of a lens that has progressively become dysfunctional with visual quality degradation. It is characterized by the loss of transparency of the lens, the inability to accommodate from which presbyopia occurs and the alteration of the aberrometric profile with increased spherical aberration and coma.
Presbyopia is the progressive and irreversible inability to accommodate that, just like the loss of crystalline transparency, all the population will develop with age. Thus, as advocated by George Waring IV, the entire population will present DLS in the course of their lives.
Different diagnostic methods have been developed that evidence the syndrome and evaluated its correlation with visual acuity and phacodinamics10, such as the crystalline densitometry evaluated by Scheimpflug camera11-12 or ray-tracing system aberrations such as iTrace Visual Function Analyzer (Tracey Technologies, Houston, TX)13. These changes are corrected by lens refractive surgery. PRELEX, first named in 2002 by R. Bruce Wallace III14, is presented as a concept in the treatment of presbyopia which emphasizes the fact that the procedure combines careful biometrics with astigmatism control with safe and predictable surgery and with constant analysis of outcomes to improve results. The PRELEX concept in the long run would lead, according to the author, surgeons to improve their results, with better rates of patient satisfaction, making the procedure increasingly popular.
PRELEX is the best surgical option for the correction of presbyopia since it is the only one that is involved in the main cause of loss of accommodation (aging of the lens) and allows a stable and definitive result to be obtained. Procedures for correction of corneal presbyopia (PresbiLASIK or intracorneal implants) have a limited efficacy over time and may compromise the future possibility of multifocal lens implantation. On the contrary in PRELEX the result is definitive only if you are anticipating a surgery that would be inevitable in the long run as the lens would eventually opacify.
For the success of this surgery a decisive contribution is made to the perfect combination of four factors:
Since the first three topics are covered in other chapters, this chapter will focus on patient selection.
Patient selection is a key step in the success of PRELEX (Table 1). Although the surgical procedure is identical, the approach of the surgeon may not be the same in cataract surgery and PRELEX. Here is an elective surgery motivated by the quest for a higher quality of life of the patient, so it should not be performed whenever there are conditions that may compromise safety, postoperative visual quality and patient satisfaction. It is therefore essential to inform the patient about the expected outcome for the procedure. This is the first step to avoid misunderstandings and dissatisfied patients. Always bearing in mind the "underpromise and overdeliver", they should be warned of the possible loss of contrast sensitivity as well as photic phenomena after surgery, which are however tolerable for most of those who undergo surgery. It is important to know the patient's lifestyle: their professional needs, their hobbies and other daily activities can condition the choice of lens to implant or, in the limit, contraindicate the surgery. Also, their personality that will be the determinant for their capacity of neuro-adaptation in cases of dysphotopsis, halos and glare in the postoperative period, should be considered. Patients with unrealistic expectations and those with hypercritical personality should be excluded.
In relation to age, the patient's refractive error must be taken into account. The hyperopic patient has a greater and earlier impairment of near visual acuity and a lower risk of postoperative complications in the posterior segment of the eye. Thus, it may be indicated to perform PRELEX in hyperopes above 45 years of age and the procedure should be reserved for myopia above 50 years of age15.
Some clinical comorbidities should be taken into account either in the choice of the lens to implant or in the exclusion of the patient. In glaucoma, the contrast sensitivity and mesopic vision are somehow compromised and therefore constitute a contraindication for PRELEX16-17.
Also, the diabetic, myopic or age-related maculopathies constitute exclusion factors for surgery.
It is also important to exclude all retinal pathology that increases the risk of complications in the postoperative period. Therefore, an examination of the periphery of the retina as well as an OCT of the retina and optic nerve is mandatory (Figure 1).
The control of astigmatism is vital for the result obtained with the implantation of a multifocal lens being accepted that patients are not tolerant of residual astigmatism greater than 0.50 D18. Thus, in addition to the possibility of resorting to toric lenses, evaluation of the cornea is fundamental. The astigmatism to be corrected and its regularity should be determined and assessed, to establish if the patient can undergo correction of residual astigmatism with excimer laser. The aberrometric profile of the cornea should also be evaluated and high-order aberrations observed, especially those associated with keratoconus.
Studies have reported that coma values above 0.32 may result in intolerable dysphotopsia in the presence of a multifocal lens19. Also, despite the fact that some authors report good results in multifocal lens implantation in patients with forms of keratoconus frustra, this pathology is a contraindication for PRELEX because of the greater possibility of errors in the biometry and the impairment of visual quality and intolerance to photic phenomena.
Asphericity influences the refractive result after intraocular lens implantation and should be taken into account in the formulas used to select the lenses, this factor being more relevant in patients already undergoing corneal refractive surgery20-21. It is also known that the ideal values of asphericity oscillate between Q = -0.15 and Q = -0.4522, so this fact must be taken into account in the preoperative evaluation and in the choice of lens to be implanted.
In patients with Fuchs' dystrophy the visual quality is compromised especially in low light and glare conditions23. On the other hand, there is an increased risk of endothelial decompensation after surgery in this group of patients. Thus, this pathology should be disregarded in the preoperative study with specular biomicroscopy and the use of PRELEX in this group of patients is contraindicated.
Dry eye is an important factor in preoperative assessment. A good ocular surface plays a key role in the outcome of surgery and dry eye is, with residual refractive error, the main cause of patient dissatisfaction after PRELEX. The tear film is the first refractive plane of the eye whereby its irregularities interfere with the patients' visual quality. Thus, the identification and categorization of dry eye is mandatory in the preoperative consultation and must be treated before surgery.
Patients with larger pupils, in addition to being associated with a worse performance of near visual acuity24, have an increased risk of glare after surgery which may vary with the lens type, with apodized diffractive lenses being more dependent on the pupil diameter. However, even considering that the size of the pupil can be altered by surgery, the pupillary diameter should be evaluated and taken into account in the preoperative evaluation, and pupils with mesopic conditions greater than 6.5 mm should not be considered for PRELEX25.
There is a correlation such as the deviation between the visual axis and the pupillary axis (kappa angle) and the photic phenomena26 and the increase of high-order coma aberrations27-28. As such, the evaluation of the kappa angle must be part of the preoperative study, usually increased in patients with hyperopia, and the implantation of lenses with a deviation greater than 40 is not recommended.
Refractive surgery in the cornea is a safe procedure with good refractive results and may correct myopia, astigmatism or hyperopia. Patients undergoing this surgery, when they become presbyopes, maintain the same motivation for the independence of the glasses that led them in the past to be operated, and therefore also seek correction of presbyopia. As previously mentioned, they are conditioning factors for the indication of PRELEX the conditions of the cornea as its curvature, asphericity, spherical aberration and coma. These parameters are altered with refractive surgery on the cornea29,30, which, in addition to the difficulty in calculating the correct power of the lens to be implanted, may be a contraindication for surgery. Previous Radial Keratotomy is always contraindicated for multifocal lens implantation due to corneal topographic irregularity. On the other hand, LASIK for low myopia is not, as a rule, an impediment to multifocal lens implantation, provided that the aforementioned asphericity and aberrometry parameters are respected31.
The implantation of aspheric multifocal lenses allows better visual acuity in glare and mesopic conditions in patients previously having undergone LASIK for correction of myopia, because they present a negative spherical aberration that compensates for the induced aberration affected in the cornea by previous surgery32.
LASIK for hyperopia correction induces spherical negative aberration and increases coma, resulting in a hyperprolated cornea with more negative values of asphericity. Thus, in eyes submitted to LASIK for correction of hyperopia, opting for a spherical multifocal lens will have an advantage to compensate for corneal asphericity33. In these cases, there is a greater risk of refractive surprise because of biometrics errors and there is a possibility of an increase in loss of contrast sensitivity.
The monofocal implant, despite the greater difficulty in the neuroadaptation due to the different quality of the images perceived by both eyes, is now acceptable in cataract surgery due to the greater independence of glasses and the functional capacity it provides. In PRELEX, the monofocal implant does not make any sense.
The implantation of mixed multifocal lenses (mix and match) that aims to provide the best of both lenses to the patient is advocated by some authors, by the theoretical better visual quality that the extended focus lenses provide and by the better near vision of the bifocal or trifocal lenses34. Critics of this option refer to the difficulty in defining the dominance of one eye and the satisfactory results obtained with the current generation of trifocal lenses, superior to those achieved with mix and match.
The diffraction of light caused by the optical design of multifocal lenses induces different focal points whereby the brain simultaneously receives different images that have to be processed to focus objects at different distances35.
This abrupt change in relation to the visual function that the patient had before the surgery, in which he had a focal point that changed, with the accommodation, to adapt to the distance to which the object was, is what makes necessary the neuroadaptation, so that the brain properly uses the different images provided by multifocal lenses. Failure of neuroadaptation can cause confusion, blurred vision, glare, and poor vision.
Neuroadaptation is an acquired process through which the brain learns to correct the image so that the final perception is as real as possible.
This process was evidenced in a study that demonstrated the association between the patients' subjective complaints and the results of functional magnetic resonances to which they were submitted36. In most cases, this process takes place in a minimum period of three months, until a significant reduction of the photic phenomena is seen, with the best possible adaptation achieved up to a year after surgery37.
Figure 2 - Evaluation of the Anterior Segment
The satisfaction rate of patients submitted to PRELEX is quite high. The main factors of dissatisfaction are blurred vision (in 95% of cases of dissatisfied patients) and photic phenomena (in about 40% of cases)38,39. Associated with these symptoms we have as main causes residual ametropia, posterior capsule opacification, dry eye, large pupils and aberrometric changes.
Likewise, there is a correlation between high satisfaction rates and low astigmatism, good visual acuity, low perception of halos and glare, and independence of glasses25.
Blurred vision, being the main factor of dissatisfaction, can in most cases be resolved. Ametropia is the main cause and in most cases results from residual astigmatism, either because an toric lens was not implanted or because it was not implanted on the correct axis or because there was an error in the calculation of the lens to be implanted. Except in cases where the solution passes by rotating the lens, it should be considered the option of correcting any astigmatism higher than 0.50 D with laser Excimer. This is one of the reasons of the importance in the preoperative evaluation of the cornea since there is always the possibility of using the laser to correct residual refractive errors. Likewise, should any surgeon who implant multifocal lenses have access to the Excimer laser. The option for PRK or LASIK should be evaluated, and dry eye is an important factor in this decision.
The second most important cause of blurred vision and photic phenomena is opacification of the posterior capsule. YAG laser capsulotomy should be considered whenever the patient has complaints of loss of visual acuity but should be reserved after other causes for this complaint have been ruled out since it is never possible to exclude the rare necessity of explanting the lens. In patients with multifocal lenses the opacity of the capsule has a greater impact on visual acuity and this opacity may condition minor astigmatisms that also contribute to blurred vision40. In relation to the photic phenomena these are in most cases related to the pupil, the lens centering and the personality of the patient25 and are more frequent in patients with multifocal lenses compared to patients with monofocal lenses.
All patients should be informed before surgery of the possibility of their occurrence and that in most cases over time, through the neuroadaptation process, complaints should disappear. The pupil, the lens centering, and the kappa angle should again be evaluated in order to exclude a poor surgical indication as the cause of the patient's complaints.
Dry eye, as well as being a cause of altered visual acuity, may cause discomfort and is a frequent cause of patient dissatisfaction and may be exacerbated by surgery, either by the incisions or by the topical medication in the postoperative period41. In these patients it is important to assess the cause of dry eye in order to minimize its impact on the quality of vision and the well-being of the patient.
In the same way that the implant should not be decided lightly, the explant of the multifocal lens should be considered as the last option. All causes of patient dissatisfaction should be excluded and corrected before proceeding to the lens explant42. And whenever the patient turns to a second surgeon, then he or she should contact the first to better understand the cause of the patient's dissatisfaction.
As it was mentioned in the beginning, the surgery of the lens is now a safe procedure with a very low rate of intraoperative complications. But the attitude of the surgeon in PRELEX cannot and should not be the same as that of a cataract patient. In the same way, the difference between refractive surgery of the lens and cataract surgery for functional vision repair must always be present.
PRELEX is a safe and effective procedure in the correction of presbyopia with a high rate of patient satisfaction and independence of glasses, and it is crucial to respect the inclusion and exclusion criteria. Complications and patient dissatisfaction, being uncommon, can be successfully resolved and corrected with adequate knowledge of the alternatives available to the surgeon.
There is scientific evidence that near visual acuity gains outweigh the reduction in contrast sensitivity and the risk of photic phenomena in patients aspiring to spectacle independence. Thus, PRELEX is a valid alternative for the benefit of all patients who have the desire for an independence of glasses and who can undergo surgery. Careful and judicious preoperative evaluation is essential since the correct selection of patients, combined with information and management of their expectations, is a key factor in the success of the procedure.