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A multicentric study of pharmacological treatment for presbyopia

Graefe's Archive for Clinical and Experimental Ophthalmology volume 259, pages 2441–2450 (2021)Cite this article

Abstract

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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Data availability

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Code availability

The software used was XLMiner Analysis ToolPak Frontline Systems Inc, which is a free software to perform statistical analysis in Google Sheets.

References

  1. Jackson M (2020) 2019 Wilkins-Bernal-Medawar lecture Life begins at 40: the demographic and cultural roots of the midlife crisis. Notes Rec R Soc Lond 74:345–364

    Article  Google Scholar 

  2. Ting DSW, Carin L, Dzau V, Wong TY (2020) Digital technology and COVID-19. Nat Med 26:459–461

    CAS  Article  Google Scholar 

  3. Wosik J, Fudim M, Cameron B et al (2020) Telehealth transformation: COVID-19 and the rise of virtual care. J Am Med Inform Assoc 27:957–962

    Article  Google Scholar 

  4. Wolffsohn JS, Davies LN (2019) Presbyopia: effectiveness of correction strategies. Prog Retin Eye Res 68:124–143

    Article  Google Scholar 

  5. Stival LR, Figueiredo MN, Santhiago MR (2018) Presbyopic excimer laser ablation: a review. J Refract Surg 34:698–710

    Article  Google Scholar 

  6. Greenwood M, Bafna S, Thompson V (2016) Surgical correction of presbyopia: lenticular, corneal, and scleral approaches. Int Ophthalmol Clin 56:149–166

    Article  Google Scholar 

  7. Pallikaris IG, Panagopoulou SI (2015) PresbyLASIK approach for the correction of presbyopia. Curr Opin Ophthalmol 26:265–272

    Article  Google Scholar 

  8. Kamiya K, Takahashi M, Takahashi N, Shoji N, Shimizu K (2017) monovision by implantation of posterior chamber phakic intraocular lens with a central hole (Hole ICL) for early presbyopia. Sci Rep 7:11302.

  9. Alió JL, Grzybowski A, Romaniuk D (2014) Refractive lens exchange in modern practice: when and when not to do it? Eye Vis (Lond) 1:10

    Article  Google Scholar 

  10. Shah DN, Melki S (2014) Complications of femtosecond-assisted laser in-situ keratomileusis flaps. Semin Ophthalmol 29:363–375

    Article  Google Scholar 

  11. Fernandes P, Gonzalez-Meijome JM, Madrid-Costa D, Ferrer-Blasco T, Jorge J, Montes-Mico R (2011) Implantable collamer posterior chamber intraocular lenses: a review of potential complications. J Refract Surg 27:765–776

    Article  Google Scholar 

  12. Benozzi J, Benozzi G, Orman B (2012) Presbyopia: a new potential pharmacological treatment. Med Hypothesis Discov Innov Ophthalmol 1:3–5

    PubMed  PubMed Central  Google Scholar 

  13. Crawford KS, Garner WH, Burns W (2014) Dioptin™: a novel pharmaceutical formulation for restoration of accommodation in presbyopes. Invest Ophthalmol Vis Sci 55:3765

    Article  Google Scholar 

  14. Abdelkader A (2015) Improved presbyopic vision with miotics. Eye Contact Lens 41:323–327

    Article  Google Scholar 

  15. Garner WH, Garner MH (2016) Protein disulfide levels and lens elasticity modulation: applications for presbyopia. Invest Ophthalmol Vis Sci 57:2851–2863

    CAS  Article  Google Scholar 

  16. Renna A, Vejarano LF, De la Cruz E, Alió JL (2016) Pharmacological treatment of presbyopia by novel binocularly instilled eye drops: a pilot study. Ophthalmol Therapy 5:63–73

    Article  Google Scholar 

  17. Tsuneyoshi Y, Higuchi A, Negishi K, Tsubota K (2017) Suppression of presbyopia progression with pirenoxine eye drops: experiments on rats and non-blinded, randomized clinical trial of efficacy. Sci Rep 7:6819

    Article  Google Scholar 

  18. Vargas V, Vejarano F, Alió JL (2019) Near vision improvement with the use of a new topical compound for presbyopia correction: a prospective, consecutive interventional non-comparative clinical study. Ophthalmol Therapy 8:31–39

    Article  Google Scholar 

  19. Benozzi G, Perez C, Leiro J, Facal S, Orman B (2020) Presbyopia treatment with eye drops: an eight year retrospective study. Transl Vis Sci Technol 9:25

    PubMed  PubMed Central  Google Scholar 

  20. Bron AJ, Evans VE, Smith JA (2003) Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea 22:640–650

    Article  Google Scholar 

  21. Chylack LT Jr, Wolfe JK, Singer DM et al (1993) The Lens Opacities Classification System III. The Longitudinal Study of Cataract Study Group. Arch Ophthalmol 111:831–836

    Article  Google Scholar 

  22. Freund AM, Ritter JO (2009) Midlife crisis: a debate. Gerontology 55:582–591

    Article  Google Scholar 

  23. Sivardeen A, McAlinden C, Wolffsohn JS (2020) Presbyopic correction use and its impact on quality of vision symptoms. Aust J Optom 13:29–34

    Article  Google Scholar 

  24. Grzybowski A, Markeviciute A, Zemaitiene R (2020) A review of pharmacological presbyopia treatment. Asia Pac J Ophthalmol 9:226–233

    Article  Google Scholar 

  25. Barany EH (1962) The mode of action of pilocarpine on outflow resistance in the eye of a primate (Cercopithecus ethiops). Investig Ophthalmol 1:712–727

    CAS  Google Scholar 

  26. Croft MA, Kaufman PL, Crawford KS, Neider MW, Glasser A, Bito LZ (1998) Accommodation dynamics in ageing rhesus monkeys. Am J Phys 275:R1885–R1897

    CAS  Google Scholar 

  27. Wendt M, Glasser A (2010) Topical and intravenous pilocarpine stimulated accommodation in anesthetized rhesus monkeys. Exp Eye Res 90:605–616

    CAS  Article  Google Scholar 

  28. Croft MA, Kaufman PL, Erickson-Lamy K, Polansky JR (1991) Accommodation and ciliary muscle muscarinic receptors after echothiophate. Invest Ophthalmol Vis Sci 32:3288–3297

    CAS  PubMed  Google Scholar 

  29. Ostrin LA, Glasser A (2007) Effects of pharmacologically manipulated amplitude and starting point on edinger-westphal-stimulated accommodative dynamics in rhesus monkeys. Invest Ophthalmol Vis Sci 48:313–320

    Article  Google Scholar 

  30. Schalnus R (2003) Topical nonsteroidal anti-inflammatory therapy in ophthalmology. Ophthalmologica 217:89–98

    CAS  Article  Google Scholar 

  31. Facal S, Leiro J, Gualtieri A, Perez C, Benozzi G, Orman (2018) Ocular surface evaluation in patients treated with pharmacological treatment for presbyopia. Int J Ophthalmic Pathol 7:2. https://doi.org/10.4172/2324-8599.1000218

    Article  Google Scholar 

  32. Benozzi G, Facal S, Leiro J, Perez C, Orman B (2020) Stereopsis evaluation in patients under pharmacological treatment for presbyopia. Oftalmol Clin Exp 13:82–89

    Google Scholar 

  33. Radner W (2017) Reading charts in ophthalmology. Graefes Arch Clin Exp Ophthalmol 255:1465–1482

    CAS  Article  Google Scholar 

Download references

Acknowledgements

The authors appreciate access to library resources at the Universidad de Buenos Aires, Buenos Aires, Argentina.

Author information

Authors and Affiliations

  1. Centro de Investigación Avanzada para la Presbicia, Buenos Aires, Argentina

    Giovanna Benozzi, Sonia Facal & Juliana Leiro

  2. Universidad de Buenos Aires, Facultad de Odontología, Cátedra de Farmacología, Buenos Aires, Argentina

    Giovanna Benozzi & Betina Orman

  3. Instituto Oftalmológico Cortina, Santa Rosa, La Pampa, Argentina

    Martín Eugenio Cortina & Gonzalo Matías Lorda

  4. Clínica de Ojos del Sud, Bahía Blanca, Argentina

    Esteban Gimeno

  5. Clínica Cimed, Puerto Iguazú, Misiones, Argentina

    Darío Lucio Vantesone

  6. Clínica de Ojos Visión Médica, Mar del Plata, Buenos Aires, Argentina

    Antonio Enrique Solas

  7. Pharmacology Unit, School of Dentistry, Universidad de Buenos Aires, M. T. de Alvear 2142 – 4to. Piso “B”, 1122AAH, Buenos Aires, Argentina

    Betina Orman

Authors
  1. Giovanna Benozzi
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  2. Martín Eugenio Cortina
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  3. Esteban Gimeno
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  4. Darío Lucio Vantesone
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  5. Antonio Enrique Solas
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  6. Gonzalo Matías Lorda
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  7. Sonia Facal
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  8. Juliana Leiro
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  9. Betina Orman
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Contributions

GB: conception, data collection, manuscript drafting, critical revision, and statistical analysis. MC: conception, data collection, manuscript drafting and critical revision. EG: data collection and manuscript drafting. DV: data collection and manuscript drafting. AS: data collection and manuscript drafting. GL: data collection and manuscript drafting. SF: data collection and manuscript drafting. JL: data collection and manuscript drafting. BO: conception, manuscript drafting, critical revision, and statistical analysis.

Corresponding author

Correspondence to Betina Orman.

Ethics declarations

Ethics approval and consent to participate

The tenets of Helsinki were followed by all the participant researchers, and the present study protocol was approved by the Ethical Committee of the Argentinian Presbyopia Society 0003/2020. Informed consent was obtained from every patient before starting the treatment.

Consent for publication

The authors approved the final manuscript for submission.

Competing interests

Giovanna Benozzi is the owner of the Patent US 8.524.758 B2- EP1.938.839 B1.

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Benozzi, G., Cortina, M.E., Gimeno, E. et al. A multicentric study of pharmacological treatment for presbyopia. Graefes Arch Clin Exp Ophthalmol 259, 2441–2450 (2021). https://doi.org/10.1007/s00417-021-05138-8

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  • DOI: https://doi.org/10.1007/s00417-021-05138-8

Keywords

  • Presbyopia
  • Pharmacological treatment of presbyopia
  • Visual acuity
  • Multicentric study