Take-home message: In a prospective study including 20 presbyopic emmetropes, treatment with a proprietary topical ophthalmic formulation (PresbV Tears) demonstrated benefit for improving near, intermediate, and far uncorrected visual acuity.
By Cheryl Guttman Krader; Reviewed by Luis Felipe Vejarano, MD
Popayán, Colombia—Results of a prospective study show that treatment with a proprietary topical ophthalmic formulation (PresbV Tears) safely and effectively increases physiological accommodation to improve uncorrected near and intermediate vision without compromising distance vision in presbyopic emmetropes, said its inventor, Luis Felipe Vejarano, MD.
“This topical agent represents a noninvasive solution for addressing presbyopia that I believe meets all of the criteria for an ideal treatment,” said Dr. Vejarano, associate professor of ophthalmology, University of Cauca, Popayán, Colombia. “It is binocular, truly accommodative, improves near, intermediate, and far vision or at least doesn´t alter it, and allows a dynamic pupil in different light conditions (“dynamic pseudoaccommodation”) that could also diminish glare and avoid decrease in contrast sensitivity.”
In addition, it is, non–toxic, causing no adverse effects on the lacrimal film, corneal epithelium or endothelial cells, macula, or trabecular meshwork, he noted.
“My personal experience using it for more than 5 years and the outcomes of patients treated in a prospective study show that it enables spectacle independence for most activities and does so without significant risks or side effects,” Dr. Vejarano said.
About the study
The study enrolled 20 patients, of whom 9 were natural emmetropes and 11 had a history of LASIK (6 using the Vejarano Method for Presbyopia). The patients ranged in age from 41 to 57 years with a mean of about 50 years.
Assessments for efficacy and safety were performed prior to instillation of a single drop in each eye and after 0.5, 1, 2, 3, 4, and 5 hours, 7 and 30 days.
“Although this study was designed to assess the efficacy and safety after using a single drop in each eye, the topical formulation is intended to be used twice daily, once in the morning and once in the afternoon,” Dr. Vejarano said.
The results showed near uncorrected visual acuity (UCVA) improved by about 2 to 3 lines in each eye and binocularly from a baseline mean of about J3.5 to about J1.5. Mean UCVA at far was 20/25 at baseline, and except for a slight decrease after 1 hour, was improved by an average of about 1 line in each eye at all follow-up measurements. Binocularly, UCVA at far increased by 1 line on average, and no patient had a loss in binocular UCVA at far.
“Whereas other presbyopia drops improve near vision by causing an extreme miosis or a myopic shift that can reduce far vision, refractive measurements in this study showed there was a maximum myopic shift of just 0.5 D that occurred only at 1 hour post-treatment,” Dr. Vejarano said.
Measurement of objective scatter index (HD Analyzer, Simovision) prior to drop instillation and after 2 hours showed no change in optical quality of the eye but an increase in the accommodative amplitude by 0.75 D. Defocus curve measurements showed a 1.25 to 1.75 D in the accommodative range at near, increase of 0.75 D also in the accommodative amplitude and, impressively 20/25 or better in all of the patients for intermediate vision, Dr. Vejarano said.
“The improvement in accommodative range was also proven using ray tracing aberrometry [iTrace, Tracey Technologies] with the same result,” he said.
Pupil diameter was also measured and found to be mildly affected by the topical treatment (“dynamic miosis”). Moreover, the measurements showed that the treatment seemed to mitigate significant pupil enlargement under scotopic conditions as well as significant contraction in photopic conditions.
Other assessments showed no changes in tear film quality or quantity, endothelial cell count, IOP, or contrast sensitivity.
Dr. Vejarano noted that he personally began using the topical drops in 2009, instilling them twice daily—once in the morning and once in the afternoon—although sometimes omitting the treatment on weekends.
After 5.5 years of use, Dr. Vejarano said his uncorrected vision at far remains unchanged while his uncorrected near vision is improved by 2 lines.
“Objective scatter index measurements show no change with time in the quality of vision, which is remarkable considering the expected decline with increasing age, and my range of accommodation measured before instilling the medication improved from 1 D 3 years ago to 1.75 D now,” Dr. Vejarano said.
Luis Felipe Vejarano, MD
This article was adapted from Dr. Vejarano’s presentation during Refractive Surgery Subspecialty Day at the 2015 meeting of the American Academy of Ophthalmology. Dr. Vejarano has a financial interest in the formulation he discussed.