Via Research Recognition Day 2024 VCOM-Carolinas

Educational Reports

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Novel use of Pilocarpine for Presbyopia Naina Kohli 1 , Avni Patel 2 , Dr. Nisha Patel M.D. 3 1. Edward Via College of Osteopathic Medicine-Carolinas 2. Thomas Jefferson High School of Science and Technology 3. St. George’s University School of Medicine

CONCLUSION & DISCUSSION The paired t-test compared each patient’s baseline vision to their near and distant vision at 30 minutes and at 4-6 hours. In both age groups, Pilocarpine 1% had statistically significant changes in near sighted vision since their p-values were less than 0.01. No changes in distance vision were observed from both age groups that received Pilocarpine, indicating that there is no impact on distance vision with this drug. Pilocarpine effectively improved near visual acuity without any harmful side effects both subjectively from the patient and objectively observed by the physician in the slit lamp exam. The data confirms the hypothesis that Pilocarpine could be administered as a medication to help with near vision, also known as presbyopia. Although Pilocarpine is currently on the market for glaucoma, its ability to change the shape of the lens gives the patient an interesting side effect of improving their near vision. As one ages, the elasticity of the lens decreases. This impacts nearly every adult and therefore makes this medication useful to anyone who suffers from presbyopia.

INTRODUCTION Presbyopia is a progressive decrease in near vision that affects nearly every adult over the age of 40. The loss of near vision is due to the inability of the lens to properly accommodate 1 . Pilocarpine is a cholinergic parasympathomimetic agent that causes pupillary miosis through contraction of the ciliary muscle, and decreases resistance to aqueous outflow 2 . Traditionally it has been used for the treatment of glaucoma to decrease intraocular pressure by decreasing resistance to aqueous outflow. Pilocarpine has accommodative abilities based on its mechanism of action. It contracts the ciliary muscle which induces contraction of the iris 2 . This allows the lens to take a more spherical shape, allowing more aqueous humor outflow. We propose that its effects on the iris and ciliary muscle enable it to decrease the effects of presbyopia in patients aged 42-59. Based on how the drug pilocarpine affects the eye, it could potentially help patients with presbyopia and eliminate the need for reading glasses. STUDY DESIGN Between June 2016 to November 2018, patients between the ages of 42 to 59 years were screened to determine if they met inclusion criteria. Participants were divided in two groups based on their age, 42-50 and 51-59, to determine if there was decreased efficacy in older populations. In this double-blind placebo based study, drug X or drug Y were administered to the patients at random. Drug X was dilute 1% Pilocarpine and drug Y was Basic Saline Solution (BSS). A 1% dilution of Pilocarpine was chosen to ensure adequate amounts of drug were delivered while minimizing medication side effects. Baseline visual acuity and intraocular pressure (IOP) were measured prior to instillation of drop X or Y. After administration of the drop, patient waited for 30 minutes after which both distance and near visual acuity were measured. Distance and near visual acuity were measured again after 4-6 hours. A slit lamp examination was performed and an exit survey was administered to screen for side effects. Image 1: Illustration of the eye changing shape based on near and distance vision 3 .

ELIGIBILITY CRITERIA Inclusion Criteria

Exclusion Criteria

• Age 42-59 • Phakic lens

• Acute angle closure glaucoma • Retinal disorders • Allergy to pilocarpine or its drug class • Breastfeeding or pregnant • History of iritis or eye trauma • Pseudophakic or aphakic lens • Refractive error larger than - 0.50 sphere or +0.50 sphere • Astigmatism (cylinder) more than +1.00 diopter • Baseline distance vision worse than 20/40

• No history of major eye diseases • No history of retinal detachments or retinal tears • Dilated eye exam in the past 3 month with pupillary assessment, intraocular pressure, extraocular muscle movements, confrontational visual fields, anterior segment exam • Dilated fundoscopic exam • Consent forms signed

RESULTS Age Group

Drop Administered

NV at 30 min P value

NV at 4-6 hours P value

DV at 30 min P value

DV at 4-6 hours P value

CURRENT APPLICATION Since completion of this study, in late 2021, a 1.25% formulation of Pilocarpine HCl was released on the market as VUITY for presbyopia correction 4 . Patients can administer one or two drops daily to reduce the need for reading glasses. The drug is FDA approved and currently available by prescription only.

42-50 Pilocarpine 1% <0.0001 0.0017 *

*

42-50 BSS 0.5165 0.2168 1.000 51-59 Pilocarpine 1% <0.0001 0.0051 0.2141 0.0284 51-59 BSS 0.3300 0.3146 0.1039 0.6714 Table 1: Paired t-test results of near and distance visual acuity of each study group. *= indicates that the differences for all the VA were identical so there was no difference Yellow highlight = indicates significant value based on p value (<0.01) 0.1803

Statistically significant

NV @30 min

Pilocarpine 1% (6)

Image 2: VUITY medication packaging 5 .

REFERENCES

Statistically significant

NV @4-6 hours

Age 42-50

NV @30 min

Not Significant

Placebo (BSS) (4)

NV @4-6 hours

Not Significant

Patients in Ophthalmology office

1. Mayo Clinic. (n.d.). Presbyopia - Symptoms and Causes. Retrieved from https://www.mayoclinic.org/diseases-conditions/presbyopia/symptoms-causes/syc 20363328#:~:text=Almost%20everyone%20experiences%20some%20degree,in%20people%20younger %20than%2040. 2. National Center for Biotechnology Information. (n.d.). Pilocarpine. In StatPearls. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK556128/#:~:text=When%20used%20as%20a%20miotic,outfl ow%2C%20miosis%2C%20and%20accommodation. 3. Price Vision Group. (n.d.). Near Vision Decline. Retrieved from https://pricevisiongroup.com/conditions/near-vision-decline/. 4. VUITY. (n.d.). How does VUITY® work? Retrieved from https://vuity.com/about vuity#:~:text=How%20does%20VUITY%C2%AE%20work,as%20directed%20by%20your%20doctor. 5. Clinical Trials Arena. (n.d.). Vuity (Pilocarpine HCl) for the Treatment of Presbyopia, USA. Retrieved from https://www.clinicaltrialsarena.com/projects/vuity-pilocarpine-hci-for-the-treatment-of presbyopia-usa/?cf-view.

Statistically significant

NV @30 min

Pilocarpine 1% (10)

Statistically significant

NV @4-6 hours

Age 51-59

NV @30 min

Not Significant

Placebo (BSS) (7)

NV @4-6 hours

Not Significant

Table 2: Schematic of participants and the significance of their outcome.

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2024 Research Recognition Day