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A multicentric study of pharmacological treatment for presbyopia

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.

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Acknowledgements

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

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Authors and Affiliations

Authors

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