RESUMEN
Presbyopia affects between 1.7 and 2 billion people worldwide. Presbyopia significantly impacts productivity and quality of life in both developed and developing countries. During accommodation, the human eye changes its dioptric power by altering the shape of the lens, but the exact nature of this change has not been fully explained. Recently, topical treatments have been marketed for the treatment of presbyopia and others are under investigation. In order to prepare a review of these novel therapies, we searched the major biomedical search engines. We found 15 randomized clinical trials and 12 reviews that met our review criteria. There are two different strategies for this purpose, the pinhole effect that increases depth of focus and "crystalline lens relaxation" for which parasympathetic mimetics and lens oxidation intermediates have been used. The results are generally favorable in terms of improvement of near visual acuity, although the follow-up period of the studies is short. These are novel strategies in the early stages of research that could be useful in the treatment of presbyopia.
Asunto(s)
Presbiopía , Presbiopía/tratamiento farmacológico , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Soluciones Oftálmicas/uso terapéutico , Agudeza Visual , CristalinoRESUMEN
Presbyopia is a global problem with an estimated 1.3 billion patients worldwide. In the area of functional food applications, dietary supplements or herbs, there are very few reports describing the positive effects of their use. In the available literature, there is a lack of studies in humans as well as on an animal model of extracts containing, simultaneously, compounds from the polyphenol group (in particular, anthocyanins) and iridoids, so we undertook a study of the effects of a preparation composed of these compounds on a condition of the organ of vision. Our previous experience on a rabbit model proved the positive effect of taking an oral extract of Cornus mas in stabilizing the intraocular pressure of the eye. The purpose of this study was to evaluate the effect of an orally administered ternary compound preparation on the status of physiological parameters of the ocular organ. The preparation contained an extract of the chokeberry Aronia melanocarpa, the honeysuckle berry Lonicera caerulea L., and the bilberry Vaccinium myrtillus (hereafter AKB) standardized for anthocyanins and iridoids, as bioactive compounds known from the literature. A randomized, double-blind, cross-over study lasting with a "wash-out" period of 17 weeks evaluated a group of 23 people over the age of 50, who were subjects with presbyopia and burdened by prolonged work in front of screen monitors. The group of volunteers was recruited from people who perform white-collar jobs on a daily basis. The effects of the test substances contained in the preparation on visual acuity for distance and near, sense of contrast for distance and near, intraocular pressure, and conjunctival lubrication, tested by Schirmer test, LIPCOF index and TBUT test, and visual field test were evaluated. Anthocyanins (including cyanidin 3-O-galactoside, delphinidin 3-O-arabinoside, cyanidin 3-O-glucoside, cyanidin 3-O-rutinoside, cyanidin 3-O-arabinoside) and iridoids (including loganin, sweroside, loganic acid) were identified as substances present in the extract obtained by HPLC-MS. The preliminary results showed that the composition of AKB applied orally does not change visual acuity in the first 6 weeks of administration. Only in the next cycle of the study was an improvement in near visual acuity observed in 92.3% of the patients. This may indicate potential to correct near vision in presbyopic patients. On the other hand, an improvement in conjunctival wetting was observed in the Schirmer test at the beginning of week 6 of administration in 80% of patients. This effect was weakened in subsequent weeks of conducting the experiment to 61.5%. The improvement in conjunctival hydration in the Schirmer test shows the potential beneficial effect of the AKB formulation in a group of patients with dry eye syndrome. This is the first study of a preparation based on natural, standardized extracts of chokeberry, honeysuckle berry, and bilberry. Preliminary studies show an improvement in near visual acuity and conjunctival hydration on the Schirmer test, but this needs to be confirmed in further studies.
Asunto(s)
Lonicera , Photinia , Presbiopía , Vaccinium myrtillus , Animales , Humanos , Conejos , Presbiopía/tratamiento farmacológico , Antocianinas , Estudios Cruzados , Agudeza Visual , Conjuntiva , IridoidesRESUMEN
PURPOSE: This study was undertaken to evaluate the safety and efficacy of CSF-1 (0.4% pilocarpine hydrochloride ophthalmic solution) for use in individuals with presbyopia. METHODS: Two Phase 3 multicenter, randomized, double-masked, vehicle-controlled, parallel-group clinical trials were conducted in 35 private ophthalmology clinics in the United States from October 2020 to February 2022. Key inclusion criteria were the following: (1) age 45-64 years, (2) distance-corrected near visual acuity (DCNVA) at 40 cm ≥0.40 and ≤0.90 logarithm of the minimum angle of resolution (logMAR, approximately 20/50-20/160 Snellen) in at least 1 eye, (3) manifest refraction (MR) between -4.50 and +2.00 diopter (D) sphere in each eye with ≤2.00D difference between eyes, (4) <2.00D of cylinder MR in each eye, (5) ≤0.04 logMAR (20/20-2 or better) corrected distance visual acuity (CDVA) at 4 m in each eye. Key exclusion criteria were the following: (1) >0.14 logMAR (7 letters) improvement in post-vehicle treatment in monocular DCNVA in either eye at visit 1, (2) introcular pressure (IOP) <9 or >22 mm Hg, (3) average dark-adapted pupillometry <3.5 mm in either eye, (4) prior refractive surgery or intraocular lens (IOL) implantation. Participants applied CSF-1 or vehicle twice per day for 2 weeks. Efficacy and safety assessments were performed at several times on days 1, 8, and 15. Response was defined as ≥3-line gain in DCNVA without loss of ≥1-line in CDVA in the study eye under mesopic room lighting conditions. The primary efficacy endpoint was measured 1 hour post-dose 1 on day 8. Key secondary endpoints were 2 hours post-dose 1, and 1 and 2 hours post-dose 2, also on day 8. Safety endpoints were ocular and non-ocular treatment-related adverse events (TRAE), conjunctival redness, drop comfort, slit-lamp biomicroscopy, intraocular pressure, indirect fundoscopy, and CDVA at 4 m. FINDINGS: Six hundred thirteen participants were randomized to CSF-1 (n = 309) or vehicle (n = 304). Participants were predominantly White (80.8%) and female (62.0%), with mean age (standard deviation) of 54.7 (4.8). CSF-1 met the primary and key secondary endpoints. At the primary endpoint, 40.1% of the CSF-1 group achieved response versus 19.1% of the vehicle group (P < 0.0001). The percentage of responders was significantly greater in CSF-1 compared with vehicle at all tested times. Changes from baseline in all safety endpoints were comparable between groups. Most adverse events (AEs) were mild and transient. Neither serious nor severe AEs were reported with CSF-1. IMPLICATIONS: CSF-1, a low-dose pilocarpine ophthalmic solution, demonstrated superiority to vehicle in improving near vision in individuals with presbyopia without compromising distance vision. CSF-1 demonstrated a favorable safety profile. CLINICALTRIALS: gov identifier: NCT04599933 (NEAR-1), NCT04599972 (NEAR-2).
Asunto(s)
Lentes Intraoculares , Presbiopía , Femenino , Humanos , Persona de Mediana Edad , Implantación de Lentes Intraoculares/efectos adversos , Implantación de Lentes Intraoculares/métodos , Factor Estimulante de Colonias de Macrófagos , Soluciones Oftálmicas/efectos adversos , Pilocarpina/efectos adversos , Presbiopía/tratamiento farmacológico , Presbiopía/complicacionesRESUMEN
PURPOSE: To assess public awareness, interest, and concerns regarding Vuity (1.25% pilocarpine hydrochloride ophthalmic solution), an eye drop for the treatment of presbyopia, based on Google Trends. METHODS: We used Google Trends that provides a relative search volume for queried terms, to evaluate searches for Vuity from June 30, 2021, to June 30, 2022, in the United States. The data for this study were downloaded on June 30, 2022. Main outcome measures were changes in relative search volumes for the terms "Vuity," "Eye drops for reading," "Eye drops for near vision," "Presbyopia," "Pilocarpine," and related popular search terms, such as "Vuity side effects," and "Vuity retinal detachment". RESULTS: Since the approval of Vuity on October 29, 2021, notable increases in the relative search volumes occurred for Vuity in October 2021, December 2021, and from March to April 2022, which coincided with its approval, availability, and subsequent direct-to-consumer advertising based on positive results of clinical trials. The direct-to-consumer advertising had the greatest impact on the search volume for Vuity. Specific interests included Vuity cost, where to buy it, and its side effects. Retinal detachment was the most highly searched Vuity side effect. Geographic variation was evident, with the relative search volumes highest for "Vuity" in Wyoming, followed by North Dakota. CONCLUSION: Google Trends is a useful tool for monitoring increases in public interest in Vuity for presbyopia. Public concerns regarding side effects warrant further real-world investigations of the causal relationship between Vuity and retinal detachment.
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Presbiopía , Desprendimiento de Retina , Estados Unidos , Humanos , Motor de Búsqueda , Presbiopía/tratamiento farmacológico , Soluciones Oftálmicas , WyomingRESUMEN
PURPOSE: To evaluate the safety, efficacy, and pharmacokinetics of pilocarpine hydrochloride 1.25% (Pilo hereafter) compared with vehicle when administered bilaterally, twice daily (6 hours apart) for 14 days in participants with presbyopia. DESIGN: Phase 3, randomized (1:1), controlled, double-masked, multicenter study. METHODS: Participants (40-55 years of age) had objective and subjective evidence of presbyopia affecting daily activities with mesopic, high-contrast, binocular distance-corrected near visual acuity (DCNVA) of 20/40 to 20/100. The primary/key secondary endpoint was the proportion of participants gaining ≥3 lines in mesopic/photopic, high-contrast, binocular DCNVA on day 14 (last study visit), hour 9 (3 hours after the second dose), with no more than a 5-letter loss in mesopic/photopic corrected distance visual acuity with the same refractive correction. Key safety measures included treatment-emergent adverse events (TEAEs) and some ocular measurements. Pilocarpine plasma levels were assessed in approximately 10% of enrolled participants. RESULTS: Overall, 230 participants were randomized to Pilo twice daily (N = 114) and vehicle (N = 116). The proportion of participants achieving the primary and key secondary efficacy endpoints was statistically significantly greater with Pilo twice daily than vehicle, with between-treatment differences of 27.3% (95% CI = 17.3, 37.4) and 26.4% (95% CI = 16.8, 36.0), respectively. The most common TEAE was headache, reported in 10 participants (8.8%, Pilo group) and 4 participants (3.4%, vehicle group). Pilocarpine's accumulation index on day 14 was ≤1.11 after the second dose. CONCLUSIONS: Near-vision improvements were statistically greater with Pilo twice daily than with vehicle, without compromising distance acuity. The safety profile of Pilo twice daily was consistent with that of Pilo once daily, and systemic accumulation was minimal, supporting twice daily administration.
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Pilocarpina , Presbiopía , Humanos , Presbiopía/tratamiento farmacológico , Agudeza Visual , Refracción Ocular , Método Doble CiegoRESUMEN
Presbyopia is an age-related vision disorder that is a global public health problem. Up to 85% of people aged ≥40 years develop presbyopia. In 2015, 1.8 billion people globally had presbyopia. Of those with significant near vision disabilities due to uncorrected presbyopia, 94% live in developing countries. Presbyopia is undercorrected in many countries, with reading glasses available for only 6-45% of patients living in developing countries. The high prevalence of uncorrected presbyopia in these parts of the world is due to the lack of adequate diagnosis and affordable treatment. The formation of advanced glycation end products (AGEs) is a non-enzymatic process known as the Maillard reaction. The accumulation of AGEs in the lens contributes to lens aging (leading to presbyopia and cataract formation). Non-enzymatic lens protein glycation induces the gradual accumulation of AGEs in aging lenses. AGE-reducing compounds may be effective at preventing and treating AGE-related processes. Fructosyl-amino acid oxidase (FAOD) is active on both fructosyl lysine and fructosyl valine. As the crosslinks encountered in presbyopia are mainly non-disulfide bridges, and based on the positive results of deglycating enzymes in cataracts (another disease caused by glycation of lens proteins), we studied the ex vivo effects of topical FAOD treatment on the power of human lenses as a new potential non-invasive treatment for presbyopia. This study demonstrated that topical FAOD treatment resulted in an increase in lens power, which is approximately equivalent to the correction obtained by most reading glasses. The best results were obtained for the newer lenses. Simultaneously, a decrease in lens opacity was observed, which improved lens quality. We also demonstrated that topical FAOD treatment results in a breakdown of AGEs, as evidenced by gel permeation chromatography and a marked reduction in autofluorescence. This study demonstrated the therapeutic potential of topical FAOD treatment in presbyopia.
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Catarata , Cristalino , Presbiopía , Humanos , Presbiopía/tratamiento farmacológico , Envejecimiento , Catarata/tratamiento farmacológico , Productos Finales de Glicación AvanzadaRESUMEN
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.
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Presbiopía , Humanos , Presbiopía/tratamiento farmacológico , Presbiopía/cirugía , Agudeza Visual , EnvejecimientoRESUMEN
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.
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Hiperopía , Queratomileusis por Láser In Situ , Presbiopía , Humanos , Queratomileusis por Láser In Situ/efectos adversos , Queratomileusis por Láser In Situ/métodos , Resultado del Tratamiento , Presbiopía/tratamiento farmacológico , Presbiopía/cirugía , Estudios de Seguimiento , Láseres de Excímeros/uso terapéutico , Hiperopía/tratamiento farmacológico , Hiperopía/cirugíaRESUMEN
PURPOSE OF REVIEW: Despite affecting approximately 1.8 billion individuals worldwide, until recently, a pharmacologic treatment for presbyopia was not available. This special commentary reviews the treatment of presbyopia with a focus on the recently approved medication Vuity (pilocarpine 1.25%, Allergan, an AbbVie Company). RECENT FINDINGS: Vuity is a re-engineered formulation of pilocarpine 1.25% specifically designed for the treatment of presbyopia. Recently published results from the GEMINI 1 Phase 3 clinical trial reported improvement in distance corrected near vision without significant compromise in distance vision. No unexpected safety findings were reported with mild headache being the most common adverse event. Notably, there were no reported cases of retinal detachment or angle closure during the 30-day phase 3 clinical trials. SUMMARY: Vuity is the first treatment designed and FDA approved to treat the growing presbyopia market. Phase 3 clinical trials demonstrated its ability to improve near vision without significant compromise in distance vision. We recognize this paradigm shift in the treatment of presbyopia and anxiously await additional treatment options for this ubiquitous condition.
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Miopía , Presbiopía , Humanos , Pilocarpina/uso terapéutico , Presbiopía/tratamiento farmacológico , Visión OcularAsunto(s)
Presbiopía , Acomodación Ocular , Humanos , Presbiopía/tratamiento farmacológico , Agudeza VisualRESUMEN
IMPORTANCE: AGN-190584 (Allergan, an AbbVie company) is an optimized topical formulation of pilocarpine hydrochloride, 1.25%, designed for managing presbyopia and enhanced with a proprietary vehicle. OBJECTIVE: To evaluate the efficacy and safety of pilocarpine hydrochloride, 1.25%, in individuals with presbyopia. DESIGN, SETTING, AND PARTICIPANTS: This vehicle-controlled, participant- and investigator-masked, randomized, phase 3 clinical study, GEMINI 1, enrolled individuals with presbyopia, aged 40 to 55 years, at 36 sites in the United States from December 21, 2018, to October 31, 2019. Analysis took place between February 2020 and December 2021. INTERVENTIONS: AGN-190584 or the AGN-190584 formulation vehicle was administered bilaterally, once daily for 30 days. MAIN OUTCOMES AND MEASURES: The proportion of participants with improvement of 3 or more lines in mesopic, high-contrast, binocular distance-corrected near visual acuity (DCNVA) at hours 3 and 6 on day 30 were the primary and key secondary efficacy end points, respectively. Safety measures included adverse events. RESULTS: Of 323 participants who were randomized, 235 (72.8%) were female and 292 (90.4%) were White. The mean (SD) age was 49.6 (3.5) years, and the baseline mean (SD) mesopic DCNVA was 29.2 (6.3) letters. A total of 163 individuals were randomized to AGN-190584 and 160 were randomized to vehicle. GEMINI 1 met its primary and key secondary efficacy end points. On day 30, hour 3, the percentage of participants with improvement of 3 or more lines in mesopic DCNVA was 30.7% (50 of 163) in the AGN-190584 group and 8.1% (13 of 160) in the vehicle group (difference, 22.5% [95% CI, 14.3%-30.8%]; adjusted P < .001). At hour 6, those percentages were 18.4% (30 of 163) and 8.8% (14 of 160), respectively (difference, 9.7% [95% CI, 2.3%-17.0%]; adjusted P = .01). At hour 8, the between-group difference in 3 or more lines of mesopic DCNVA gains was not statistically significant, but clinically relevant prespecified outcome measures demonstrated AGN-190584 superiority to vehicle in least-squares mean (SE) mesopic DCNVA change from baseline at hour 8 (5.4 [0.51] vs 3.6 [0.52] letters; P = .009) and photopic distance-corrected intermediate visual acuity at hour 8 (3.9 [0.44] vs 2.4 [0.45] letters; P = .01) and hour 10 (3.5 [0.46] vs 1.7 [0.47] letters; P = .004). No participants with mesopic DCNVA improvement of 3 or more lines at hour 3 had losses of more than 5 letters in mesopic, high-contrast, binocular-corrected distance visual acuity. The onset of effect was at 15 minutes. AGN-190584 demonstrated an acceptable safety and tolerability profile. CONCLUSIONS AND RELEVANCE: AGN-190584 demonstrated superiority over vehicle in mesopic DCNVA on day 30, hours 3 and 6, with an acceptable safety profile. AGN-190584 is a safe and efficacious topical therapy for presbyopia through 30 days. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03804268.
Asunto(s)
Visión de Colores , Presbiopía , Femenino , Humanos , Masculino , Pilocarpina , Presbiopía/tratamiento farmacológico , Resultado del Tratamiento , Agudeza VisualAsunto(s)
Acomodación Ocular/efectos de los fármacos , Ojo/efectos de los fármacos , Agonistas Muscarínicos/administración & dosificación , Pilocarpina/administración & dosificación , Presbiopía/tratamiento farmacológico , Administración Oftálmica , Ojo/fisiopatología , Humanos , Agonistas Muscarínicos/efectos adversos , Soluciones Oftálmicas , Pilocarpina/efectos adversos , Presbiopía/diagnóstico , Presbiopía/fisiopatología , Resultado del TratamientoRESUMEN
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.
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Acomodación Ocular/efectos de los fármacos , Soluciones Oftálmicas/administración & dosificación , Guías de Práctica Clínica como Asunto , Presbiopía/tratamiento farmacológico , Agudeza Visual , Humanos , Presbiopía/fisiopatologíaRESUMEN
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.
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Presbiopía , Adulto , Humanos , Persona de Mediana Edad , Satisfacción del Paciente , Presbiopía/tratamiento farmacológico , Refracción Ocular , Estudios Retrospectivos , Resultado del Tratamiento , Visión Binocular , Agudeza VisualAsunto(s)
Tecnología Disruptiva/métodos , Aprobación de Drogas/legislación & jurisprudencia , Desarrollo de Medicamentos/legislación & jurisprudencia , Medicamentos Genéricos/normas , Administración Tópica , Antibacterianos/administración & dosificación , Antibacterianos/uso terapéutico , Productos Biológicos/uso terapéutico , Desarrollo de Medicamentos/métodos , Medicamentos Genéricos/provisión & distribución , Síndromes de Ojo Seco/tratamiento farmacológico , Equipos y Suministros/provisión & distribución , Distrofia Endotelial de Fuchs/tratamiento farmacológico , Terapia Genética/métodos , Humanos , Soluciones Oftálmicas/administración & dosificación , Presbiopía/tratamiento farmacológico , Enfermedades de la Retina/tratamiento farmacológico , Estados Unidos , United States Food and Drug AdministrationRESUMEN
OBJECTIVES: This study evaluated the safety of topical lipoic acid choline ester (UNR844, 1.5%) ophthalmic solution and its efficacy in improving distance-corrected near visual acuity (DCNVA) in subjects with presbyopia. SUBJECTS AND METHODS: This was a prospective, randomized, double-masked, and multicentre clinical trial. Subjects with a diagnosis of presbyopia (n = 75) were randomized 2:1 to UNR844 or placebo. On days 1-7, all subjects were dosed unilaterally (twice a day, b.i.d.) in their non-dominant eye to ensure safety and tolerability prior to days 8-91 when dosing was changed to bilateral (b.i.d.). Clinical assessments, including DCNVA and adverse events (AEs), were recorded at each study visit. Patients who completed the study were recruited into a non-interventional follow-up study that monitored them until 7 months after their final UNR844 exposure. The primary endpoints were safety and the mean change in DCNVA from baseline in the study eye. RESULTS: UNR844 administration (n = 50) produced no safety concerns and was well-tolerated, with no clinically-relevant changes in best-corrected distance visual acuity, pupil size, intraocular pressure, or discontinuations due to adverse events. DCNVA improved in the study eye in the UNR844 group compared to placebo during the 91 days of treatment [UNR844 vs. placebo, mean change in LogMAR (SD); -0.159 (0.120) vs. -0.079 (0.116)]. Bilateral DCNVA improved, with 53.1% UNR844 vs. 21.7% placebo subjects gaining ≥10 letters. Improvements in DCNVA were sustained at 5 and 7 months after UNR844 dosing ceased. CONCLUSIONS: These results support further development of UNR844 ophthalmic solution for the treatment of presbyopia.
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Presbiopía , Ácido Tióctico , Colina , Ésteres , Estudios de Seguimiento , Humanos , Soluciones Oftálmicas , Presbiopía/tratamiento farmacológico , Estudios Prospectivos , Agudeza VisualRESUMEN
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.
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Presbiopía , Adulto , Argentina , Humanos , Persona de Mediana Edad , Soluciones Oftálmicas , Presbiopía/tratamiento farmacológico , Refracción Ocular , Estudios RetrospectivosRESUMEN
Presbyopia reduces an individual's ability to perform visual tasks at near distances. It is a global problem, affecting over a billion people worldwide. Contact lenses, glasses, refractive surgery, and intraocular lens surgery are the main modalities in presbyopia treatment, although they all have some disadvantages. Thus, there is an increasing need for effective, easy-to-use, and noninvasive approaches for treating presbyopia while not limiting patients' daily activities. Pharmacological presbyopia treatment as an alternative method has been under investigation in recent years. We reviewed all relevant articles using the keywords "presbyopia," "presbyopia treatment," "pharmacological presbyopia treatment," and "presbyopic corrections" from 2010 to February 9, 2020, and summarized the main results of clinical trials, investigating the drops used for presbyopia treatment.
Asunto(s)
Acomodación Ocular/efectos de los fármacos , Inhibidores de la Ciclooxigenasa 2/uso terapéutico , Agonistas Muscarínicos/uso terapéutico , Presbiopía/tratamiento farmacológico , Refracción Ocular/fisiología , Acomodación Ocular/fisiología , Quimioterapia Combinada , Humanos , Soluciones Oftálmicas , Presbiopía/fisiopatología , Resultado del TratamientoRESUMEN
PURPOSE: To summarize the pharmacological strategies that are being explored for presbyopia correction. METHODS: The review concentrates on pharmacologically induced pupillary miosis to increase depth-of-focus and lens softening or other measures to restore active accommodation. RESULTS: Several studies suggest that near vision improves and distance vision is unaffected for many hours after either monocular or binocular instillation of any one of several drug combinations that cause miosis. Unfortunately, in most studies, measurements were limited to photopic visual acuity for near and distance vision, whereas it is anticipated that pupil constriction may have adverse effects on mesopic and scotopic vision. It is not clear whether improved near vision was due entirely to increased depth-of-focus, or whether, for example, a drug-induced myopic shift in refraction was also involved. Currently, no study has provided direct evidence for drug-induced restoration/enhancement of true accommodation involving an ocular power change. CONCLUSIONS: Although it is possible that, in the future, pharmacological drops may offer a safe and reliable solution for presbyopia correction, more evidence of their effectiveness and limitations is required. [J Refract Surg. 2019;35(12):803-814.].