Daily Eye Drops Could Make Reading Glasses Unnecessary

With age, everyone develops presbyopia—a difficulty seeing close objects and text clearly—and often has to resort to reading glasses. However, the solution could be as simple as using special eye drops two to three times a day. A retrospective study of 766 patients presented at the 43rd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) found that the majority were able to read two, three, or more lines on the eye chart used to test near vision acuity (the Jaeger chart) after using specially formulated eye drops. This improvement lasted for up to two years.

How Special Eye Drops Help With Presbyopia

Dr. Giovanna Benozzi, director of the Center for Advanced Research on Presbyopia in Buenos Aires, Argentina, said, “We conducted this research because of the significant unmet medical need in the field of presbyopia treatment. Current solutions such as reading glasses or surgical procedures have limitations, including inconvenience, social discomfort, and potential risks or complications. There is a group of presbyopia patients who have limited options beyond glasses and are not candidates for surgery; these are the focus of our interest. We wanted to provide solid clinical evidence for an innovative pharmacological solution to offer patients a non-invasive, convenient, and effective alternative.”

The eye drops, developed by Dr. Benozzi’s father, the late Dr. Jorge Benozzi of the same center, contain a combination of two active ingredients: Pilocarpine, a drug that constricts the pupils and contracts the ciliary muscle, a muscle that controls the eye’s accommodation for seeing objects at different distances, and diclofenac, a nonsteroidal anti-inflammatory drug (NSAID) that relieves inflammation and the discomfort often caused by pilocarpine. Patients administered the eye drops twice daily, usually after waking up and about six hours later, with an optional third dose if symptoms recurred or additional visual comfort was required. The patient group (373 women and 393 men with an average age of 55) was divided into three groups, each receiving one of three eye drop formulations. Each formulation contained a fixed dose of diclofenac, but the pilocarpine concentrations were 1%, 2%, and 3%.

The researchers assessed the improvement in the readability of the Jaeger chart without reading glasses (uncorrected near visual acuity) one hour after the first administration of the drops and observed the patients for two years. Dr. Benozzi reported at the congress: “Our most important finding was a rapid and sustained improvement in near vision at all three concentrations. One hour after the first administration of the drops, patients had an average improvement of 3.45 Jaeger lines. The treatment also improved focusing at all distances. Impressively, 99% of the 148 patients in the 1% pilocarpine group achieved optimal near vision and were able to read two or more additional lines. Approximately 83% of all patients maintained good functional near vision after 12 months. Importantly, no significant adverse events such as increased intraocular pressure or retinal detachment were observed.” In the 2% group, 6% of the 248 patients were able to read three or more additional lines on the Jaeger chart, and in the 3% group, 84% of the 370 patients were able to read three or more additional lines.

Tolerable Alternative to Conventional Treatment of Presbyopia

The improvement in patients’ vision lasted up to two years, with a median duration of 434 days. Adverse effects were mild, with the most common being temporary visual disturbances, which occurred in 32% of cases, irritation when instilling the drops (3.7%), and headaches (3.8%). No patient discontinued treatment. Common side effects of pilocarpine may also include eye redness, watery eyes, blurred or dark vision, sensitivity to light, or problems shifting focus between objects, seeing flashes of light or “floaters” in the field of vision, and, in rare cases, retinal detachment.

Dr. Benozzi continued, “Almost all patients showed positive improvements in near visual acuity, with the extent of improvement depending on the condition of their vision prior to treatment at the start of the study. Our study found that optimal pilocarpine concentrations can be tailored individually, depending on the baseline presbyopia, which was assessed using initial Jaeger scores. Patients with less severe presbyopia responded best to concentrations of 1%, while patients with more advanced presbyopia required higher concentrations of 2% or 3% to achieve significant improvement in vision.” She concluded that these results suggest that this combination therapy is a safe, effective, and well-tolerated alternative to conventional treatment for presbyopia. It significantly reduces dependence on reading glasses and offers patients a convenient, non-invasive option, even though these eye drops may not eliminate the need for glasses in all individuals.

Importantly, according to Dr. Benozzi, this treatment is not intended to replace surgical procedures, but rather to serve as a valuable solution for patients who need safe, effective, and personalized alternatives and want to free themselves from the inconvenience of glasses. Ophthalmologists now have an evidence-based pharmacological option that expands the spectrum of presbyopia treatment beyond glasses and surgery. In addition to the patient group in this study, Dr. Benozzi has other patients who have been treated with this medication for more than ten years. Dr. Benozzi plans to conduct further research to measure the improvement in quality of life for patients and to investigate the underlying physiological mechanisms of the eye drops.

More Comprehensive, Long-Term Studies Needed

The strengths of the study include the large number of patients included and the long follow-up period. It is the first systematic evaluation comparing three different concentrations of pilocarpine in combination with diclofenac. One limitation is that it is a retrospective, single-center study, which may limit the generalizability of the results and lead to selection bias.

The president-elect of the ESCRS, Professor Burkhard Dick, chair of the Department of Ophthalmology at the University Eye Clinic in Bochum, was not involved in the research. He commented: “Although surgery has made advances in age-related near vision loss, some patients are not eligible for it. Dr. Benozzi’s retrospective, single-center study suggests that eye drops containing pilocarpine and diclofenac can improve near vision for up to two years, but due to the limited design, the results may not be transferable to all patients. Long-term use of pilocarpine can sometimes cause side effects such as reduced night vision, poorer vision in low light, eye strain, irritation, and, in rare cases, retinal detachment, while prolonged topical use of NSAIDs may pose risks to the cornea. More comprehensive, long-term, multicenter studies are needed to confirm the safety and efficacy of this treatment before it can be widely recommended.”