Pharmacological Treatment of Presbyopia by Novel Binocularly Instilled Eye Drops: A Pilot Study

Abstract

Purpose: The feasibility, in terms of safety and potential efficacy, of a new drug combination for binocular use as a noninvasive pharmacological solution for treating presbyopia was examined.

Methods: Fourteen emmetropic presbyopic subjects (28 eyes) were given one drop of the preparation under study in each eye. For each patient, the uncorrected distance visual acuity, uncorrected near visual acuity, near and far refraction, best corrected visual acuity, best corrected far-near visual acuity, photopic and scotopic pupil size, Schirmer's test, endothelial cell count, intraocular pressure, keratometry, pachymetry, and anterior chamber depth were all performed or assessed prior to the administration of the eye drops and then 0.5, 1, 2, 3, 4, and 5 h, 1 week, and 1 month post-administration prospectively in each eye and binocularly.

Results: The results showed that near uncorrected visual acuity improved by about 2-3 lines from baseline in each eye and binocularly. There was no degradation in uncorrected far vision in each eye and binocularly in any patient. Refractive measurements performed in this study showed there was a maximum myopic shift of just 0.5 D that progressively reduced and disappeared at 4 h.

Conclusion: The new topical drug treatment analyzed herein significantly improved near vision without affecting far vision. This binocular pharmacologic treatment of presbyopia has the potential to ameliorate the reading vision of presbyopes and possesses the advantages of a nonmonovision therapy. A randomized, controlled, double-masked clinical trial with a twice-a-day treatment schedule is ongoing at our institution.

Funding: This study was supported in part by the Spanish Ministry of Health, Instituto Carlos III, Red Temática de Investigación Oftalmológica (OFTALRED), and Fundación Oftalmológica Vejarano (Popayán, Colombia).

Keywords: Accommodation; Administration; Binocular; Combination; Drug therapy; Ocular; Ophthalmic; Presbyopia; Vision.

Fig. 1

Trends in best near addition (a), monocular (b), and binocular (c) near visual acuity with best far spectacle correction over time from 30 min to 1 month after instillation of the eye drops into the 28 studied eyes. Asterisks indicate values that are significantly different from the baseline. Best near addition and monocular near visual acuity with best far spectacle correction did not show any statistically significant changes. Binocular near visual acuity with best far spectacle correction only showed significant changes at 4 h post-instillation and at 1 month post-instillation

Fig. 2

Trends in binocular far uncorrected visual acuity (a), defocus equivalent (b), and binocular near uncorrected visual acuity (c) over time from 30 min to 1 month after instillation of the eye drops into the 28 studied eyes. Asterisks indicate values that are significantly different from the baseline. Binocular far uncorrected visual acuity and defocus equivalent did not show any statistically significant changes. Binocular near uncorrected visual acuity gradually improved over the course of 5 h following eye drop instillation

Fig. 3

Trends in monocular far (a) and near (b) uncorrected visual acuity and intraocular pressure (c) over time from 30 min to 1 month after instillation of the eye drops into the 28 studied eyes. Asterisks indicate values that are significantly different from the baseline. Intraocular pressure was only significantly lower at 5 h after eye drop instillation. Far uncorrected visual acuity did not show any statistically significant changes. Near uncorrected visual acuity gradually improved over the course of 5 h following eye drop instillation

Fig. 4

Trends in photopic pupil diameter (a), spherical equivalent (b), and scotopic pupil diameter (c) over time from 30 min to 1 month after instillation of the eye drops into the 28 studied eyes. Asterisks indicate values that are significantly different from the baseline. Pupil diameter under photopic conditions increased significantly for the first hour. Under scotopic conditions, pupil diameter did not change significantly until 3 h after eye drop instillation, and it then significantly decreased between 4 and 5 h after instillation. Spherical equivalent improved for 3 h following eye drop instillation