Pharmacological strategies for treating presbyopia.

PURPOSE OF REVIEW: Presbyopia is the normal progressive loss of accommodation, which leads to the inability to focus clearly on objects located at different distances. Some of the accepted methods for treating this condition are glasses, contact lenses, and surgery. Pharmacological treatments are a new and promising noninvasive option for dealing with presbyopia. The aim of this review is to provide an update on some recent advances in this field. RECENT FINDINGS: Currently, there are three different strategies for the pharmacological treatment of presbyopia. The first one aims to produce miosis and increase depth of focus through a pinhole effect, therefore improving uncorrected near visual acuity. The second one tries to restore the elasticity the lens has lost due to aging. Finally, the third strategy is based on rehabilitating accommodation; which is to say, in a binocular way, allowing for good vision at all distances. SUMMARY: Pharmacological treatments are a new alternative that expands the diversity of existing strategies for treating presbyopia. These treatments are based on the instillation of eyedrops with different compositions, which vary according to the different strategies. Many of these developments will most likely be on the market in the next few years. If the process of patient selection is done properly, any one of these three strategies can be used successfully.

A multicentric study of pharmacological treatment for presbyopia.

PURPOSE: To evaluate the safety, efficacy, and patient satisfaction with a pharmacological treatment of presbyopia performed with the Benozzi's method. METHODS: A non-randomized multicentric case-series retrospective study was developed. Were included patients from 5 centers of Argentina, from January 2010 to June 2019, aged at baseline between 40 and 60 years old, with binocular uncorrected distance visual acuity (UDVA) of 25/20 or better, and with uncorrected near visual acuity (UNVA) at least Jaeger (J) 2 or worse. The treatment was performed with a patented formulation (pilocarpine and diclofenac preservative-free eye drops). The main outcome was binocular UNVA and UDVA. Differences were evaluated by paired t-test. The presence of side effects and patient's satisfaction were also evaluated. Data was analyzed in separated groups according to their follow-up time, from 2 to 10 years. RESULTS: A total of 148 patients were included. At baseline, the UNVA for the different groups were between J3 and J8 which was improved to J1 to J2. The mean baseline UDVA has been ranged between 0.02 and 0.04 logMAR. The mean baseline UDVA has been ranged between 0.02 to 0.04 logMAR, after treatment were between 0.01 to 0.03, without a statisticallysignificant improvement. Side effects were spontaneously resolved, and subjective evaluation shows that patients were satisfied. CONCLUSIONS: This first multicentric shows that Benozzi's method for presbyopia treatment was safety and improves the UNVA without affecting the UDVA, maintaining their efficacy even after 10 years, in a population aged between 40 and 60 years old, from different ophthalmic centers in Argentina.

Pharmacological Treatments for Presbyopia.

Accommodation is the change in dioptric power of the eye. It is a dynamic process that allows focusing on an object at all distances. In order to focus sharply, three physiological responses, known as the triad of accommodation, are produced by a change in pupil size, a change in shape and position of the lens, and ocular convergence. This is modulated by the autonomic nervous system, mainly the parasympathetic nervous system. Presbyopia is a refractive condition that occurs with aging, usually manifesting around 40-50 years of age, and is a result of the loss of accommodation in the eye, causing loss of visual performance when focusing on objects placed at different distances, starting with near vision. Glasses, contact lenses, surgical approaches and now pharmacological treatments are accepted methods of treating presbyopia. Pharmacological treatment is a promising new noninvasive option for treating presbyopia. Currently there are three pharmacological approaches to the treatment of presbyopia. The first one aims to produce miosis and, from a pinhole effect, increase depth of focus, and therefore improve uncorrected near visual acuity (UNVA). The second one addresses rehabilitating accommodation in a binocular way, allowing good vision at all distances. Finally, the third strategy uses lipoic acid to restore the lost elasticity of the lens. All of these pharmacological treatments are topical non-invasive eyedrops, with no serious adverse effects having been reported with any of the strategies, and require the right patient selection process to fulfill expectations and needs. The aim of this article is to provide an update on recent advances in this field.

Hyperopic LASIK Enhanced by Pharmacological Treatment of Presbyopia.

Purpose: Regression of the refractive outcome is a major concern of LASIK procedures mainly in presbyopic patients. The purpose of this study was to evaluate the long-term efficacy of the pharmacological treatment of presbyopia performed with Benozzi's method, in combination with hyperopic LASIK surgery in presbyopic population. Methods: A nonrandomized case series was developed, including presbyopic patients who underwent bilateral "Hyperopic LASIK surgery" and were pharmacologically treated with Benozzi's Method from January 2011 to August 2018, with at least 2 years of follow-up, at two private ophthalmological clinics of Argentina. Main outcomes were spherical equivalent (SE), uncorrected distance visual acuity (UDVA), and uncorrected near visual acuity (UNVA). Measurements were evaluated at baseline and postoperative at 1 month (without Benozzi's treatment), 2 months (starting with Benozzi's treatment), and 2 years. The SE stability across the time was statistically compared. Results: A total of 84 eyes of 42 patients, with a mean age at the time of the surgery of 51.07 ± 4.5 (42-59), were found following 2 years of follow-up. Patients have improved and maintained UDVA, achieving Jaeger 1 in the second postoperative month, which was maintained up to the last year of follow-up. Refractive stability across the time is observed comparing first month after surgery with the last year of follow-up, without statistical significant difference (p: 0.11). Conclusion: Hyperopic presbyopic patients that underwent LASIK surgery and 1 month after surgery started with the pharmacological treatment of presbyopia (Benozzi's method) results in excellent UNVA and UDVA that is stable over time without refractive regression.

Presbyopia Treatment With Eye Drops: An Eight Year Retrospective Study.

Purpose: The purpose of this study was to evaluate the safety and efficacy across time, of patients topically treated with Benozzi's method for presbyopia. Methods: A nonrandomized case series retrospective study was developed, including patients with emmetropia with binocular uncorrected distance visual acuity (UDVA) of 25/20 or better, and with uncorrected near visual acuity (UNVA) at least Jaeger 2 or worse. The study was set in Buenos Aires, Argentina, from January 2011 to June 2018, with at least 1-year follow-up. Patients were treated with pilocarpine and diclofenac preservative-free eye drops (Benozzi Method; US 8.524.758 B2, EP1.938.839 B1), and the main outcome measured was binocular UNVA at different follow-up times. Other parameters, as the UDVA and presence of side effects, were evaluated. Results: A total of 910 patients were included with a mean age at baseline of 48.67 ± 3.72 years old (range, 40-59 years). The baseline UNVA was 4.74 ± 1.53 and at 8 years of follow-up was decreased to 1.36 ± 0.48 (Jaeger scale). The mean binocular UDVA at baseline was 0.00 ± 0.01 logarithm of the minimum angle of resolution (logMAR) and after 8 years of follow-up was 0.03 ± 0.04 logMAR. All side effects reported (decrease of light perception, headaches, symptoms of ocular surface dryness, and dizziness) were spontaneously resolved in patients who continued with the treatment. Conclusions: The efficacy of the pharmacological treatment of presbyopia to improve the UNVA without affecting the UDVA is shown. Side effects were well tolerated and resolved before 1 year of treatment. Translational Relevance: This is a nonsurgical option for patients with emmetropic presbyopia who do not wish to wear glasses, which is a pharmacological treatment with eye drops.

Developmental changes in accommodation evidenced by an ultrabiomicroscopy procedure in patients of different ages.

We demonstrate that changes in the behaviour of the contractile ciliary muscle accompanied by augmented rigidity of the lens are the most important aspects in the loss of accommodation. With ultrabiomicroscopy (UBM), we demonstrated that the performance of the ciliary muscle is diminished and accompanied by rigidity of the lens. Both lens thickness and trabecular-ciliary process distance (TCPD) were the parameters that showed major alterations with the loss of accommodation in patients of different ages. The results indicated that the differences between these parameters in farsightedness and nearsightedness in the different groups of patients were positively correlated.

Presbyopia: a new potential pharmacological treatment.

Presbyopia occurs after 40 years of age in humans with a progressive loss of accommodation. Accommodation depends on the contraction of the ciliary muscle and iris, lens changes and convergence. The parasympathetic system regulates the degree of ciliary muscle and iris contraction necessary to modify the shape and position of the lens and its stimulation is effective through the activation of muscarinic receptors that are present in both structures. The hypothesis proposed here suggests the correction of accommodation in emmetropic presbyopic patients using a pharmacological treatment that includes a cholinergic agent combined with non-steroidal anti-inflammatory drugs (NSAIDs). This drug combination can restore near vision without affecting distance vision. It is important to note that the pharmaceutical form used was devoid of any inflammatory or other collateral effects.