Near Vision Improvement with the Use of a New Topical Compound for Presbyopia Correction: A Prospective, Consecutive Interventional Non-Comparative Clinical Study

Abstract

Introduction To report the outcomes in near vision, optical quality and pupil diameter of a new pharmacological therapy (FOV tears) for presbyopia. Methods This was a prospective, consecutive, interventional, non-comparative clinical study in which 117 presbyopic patients were given one drop of the novel therapy (FOV tears) in each eye, followed 2 h after the instillation of the eye drop by an evaluation of the binocular uncorrected near visual acuity (UNVA) and uncorrected distance visual acuity. The objective scatter index and pupil diameter under photopic and scotopic conditions before and after instillation were also assessed. The patients were divided into two groups according to their age, with group 1 patients being 41 and 50 years old and group 2 patients, between 51 and 65 years old. Results The mean age of the patients was 50.2 years. The mean UNVA before the use of the eye drop was 0.35 LogMAR, which improved to 0.16 LogMAR at 2 h after the use of the eye drop ( p = 0.000). Nine patients did not show an improvement in UNVA, but no patient showed a loss of lines. Fourteen patients (11.9%) reported headaches as a side effect of the therapy. Conclusion This pharmacological therapy improved near vision by one or more lines (mean improvement 0.18 lines) in 92.3% of the patients at 2 h following the instillation of the eye drops. The group with the youngest patients gained more lines than the group with the oldest patients.

Pharmacological Therapy for Presbyopia in Patients with Previous Corneal Refractive Surgery: A Pilot Study

“…The results of this study shows that near vision improved significantly in all groups 2 h after the instillation of the eye drop. These results correlate with those obtained in our previous studies [ 8 , 9 ].…”

“…Some topical treatments have been studied [6][7][8][9][10], reporting an improvement in near vision with the topical application of muscarinic cholinergic agonists. We previously reported our results with a new pharmacological therapy (FOV tears) for presbyopia [8,9]. The aim of this study is to report the near visual outcomes and evaluate the potential of FOV tears in patients with previous corneal refractive surgery.…”

Overview of pharmacological treatments for presbyopia

“…In this case, the ophthalmic formulation combined pilocarpine 0.247%, with the NSAID nepafenac 0.023%, with the addition of phenylephrine (0.78%), pheniramine (0.034%), naphazoline (0.003%), and polyethylene glycol (0.09%). This group has published 2 papers regarding their pharmacological treatment results [32,43]. The first paper, from 2016, by Renna et al, studied the safety and potential efficacy of this ophthalmologic formulation in 14 patients (9 natural emmetropes, 5 stable emmetropes post-LASIK), with an age range of 41-55 years.…”

“…The second paper, by Vargas et al, in 2019, reported a prospective, consecutive, interventional, noncomparative clinical study on 117 patients with presbyopia, using 1 drop FOV tears (composed of 0.247% pilocarpine, 0.78% phenylephrine, 0.09% OVERVIEW OF PHARMACOLOGICAL TREATMENTS FOR PRESBYOPIA polyethyleneglycol, 0.023% nepafenac, 0.034% pheniramine, and 0.003% naphazoline) in each eye, and assessed UNVA and UDVA 2 hours after instillation of eye drops. The patients were divided into 2 age groups: group 1, aged 41-50 years; and group 2, aged 51-65 years.…”

“…A significant reduction in mean pupil size under photopic and scotopic conditions was detected at 2 h after treatment. Both groups showed a statistically significant change under both light conditions; however, the change in pupil size between photopic and scotopic conditions was not significant [43]. Table 2 summarizes studies which evaluated the efficacy and security of pharmacological treatment for presbyopia by restoring accommodation.…”