The Benozzi® Method (Pilocarpine Eye Drops) for the Treatment of Presbyopia

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; GLUJOVSKY, D.; ALCARAZ, A.; LOPEZ, A.; BARDACH, A.; CIAPPONI, A; ROMANO, M

Documento de Evaluación de Tecnologías Sanitarias

IECS

Año: 2012 p. 1 - 30

1668-2793

Presbyopia is a condition in which the crystalline lens of the eye loses flexibility; this makes it difficult to focus on close objects. It is a condition associated with normal aging and it presents after forty as a progressive reduction in the capability to clearly see and focus on the reading plane. It is estimated to affect one third of the U.S. population and half of the Asian population over 45 years old. Treatment options for the optical correction of presbyopia include bifocals and trifocals, progressive glasses or separate reading glasses; these may be associated with contact lenses. With age, the crystalline lens loses its flexibility. The ciliary muscle controls this movement and is supported by ligaments called zonules with sympathetic and parasympathetic innervation. This parasympathetic innervation eases flexibility and therefore pilocarpine (a parasympathetic-agonist drug) is proposed to be efficacious for the treatment of presbyopia. Technology The Benozzi® Method is a topical pharmacological treatment for presbyopia correction using ophthalmic drops daily. This is prescription ophthalmic drops for a magistral formula invented by Dr. Jorge Benozzi, containing a combination of drugs: a parasympathetic-agonist drug (pilocarpine) and a non steroidal anti-inflammatory drug (non specified). Jointly, these drugs act on the ciliary muscle in charge of making the necessary changes so that the crystalline lens can adequately focus. Thus, the patient might do without glasses. Purpose To assess the evidence available on the efficacy, safety, and other issues related to the coverage policies of the Benozzi® Method (pilocarpine ophthalmological drops) for the treatment of presbyopia. Methods A bibliographic search was carried out on the main databases (MEDLINE, Cochrane, DARE, NHS EED, EMBASE, LILACS, TripDatabase), on Internet general search engines, in health technology evaluation agencies, health sponsors and clinical trial databases. Priority was given to the inclusion of systematic reviews; controlled, randomized clinical trials (RCTs); health technology assessments and economic evaluations; clinical practice guidelines and coverage policies of other health systems. Results By using the previously described search strategies, no scientific publications were found on the effectiveness and safety of the Benozzi® Method. Two studies on the effect of topical application of 2% pilocarpine hydrochloride on the eye were found. In the first one from 1973, 20 eyes from 10 volunteers with presbyopia were studied; average age was 69 years old. Crystalline thickening was measured by high-resolution ultrasound imaging 15 minutes before and after an only pilocarpine application. Eighty five percent of the eyes assessed had effect on the anterior chamber of the eye and on the crystalline thickness (enhacing accommodation). The second study published in 1996, evaluated the relation between age and ocular effects on accommodation of topical pilocarpine. Thirty normal volunteers were enrolled (mean age 49.3 ± 3.2 years) and refraction and intraocular pressure through refractometry and applanation tonometry were determined before and one hour after instilling a 2% or 6% pilocarpine drop. The pilocarpine treated eyes showed significant responses to both doses (i.e. post-pilocarpine effect on accommodation-refraction compared to baseline), more in younger subjects. Four clinical practice guidelines were found; they agreed that the treatment for optical correction of presbyopia include bifocals, trifocals, progressive glasses or separate reading glasses; these may be associated with contact lenses. None of them mention the Benozzi® Method or pilocarpine eye drops as treatment alternatives. Conclusions There is little and poor quality evidence (few patients and no significant measurement outcomes for patient´s sight) on pilocarpine hydrochloride eye administration in patients with presbyopia. The adverse effects and potential effectiveness that topical long-term administration of pilocarpine eye drops and NSAIDs (no steroidal analgesics) might have with the Benozzi® Method are unknown since there is no supportive scientific evidence. Currently, there are no publications that endorse the use of this method.