Ciclopsorin 0.1% topical as a prophylactic treatment in the treatment of age-related ocular surface decompensation; Non-profit prospective controlled interventional study in a population of patients undergoing phacoemulsification surgery.

Project objectives

The ocular surface is a morpho-functional unit that includes the major lacrimal glands, conjunctiva, cornea, tear film, immune cells, blood and lymphatic vessels, and nerve fibers that cooperate to maintain the homeostasis that allows function visual.

Through reparative mechanisms the system is capable of reaching the physiological homeostatic balance in the context of daily stimuli and insults.

Among the methodologies aimed at evaluating the state of the ocular surface we find objective methods such as fluorescein staining, the Schirmer test, the T-BUT and conjunctival impression cytology and subjective methods using validated questionnaires. Laboratory analyzes include conjunctival impression cytology carried out to evaluate the quantity and pattern of T cells, epithelial inflammatory markers (HLA-DR and I-CAM1) and the cytokine profile of Th1 and Th17 lymphocytes.

In many body districts, such as the cardiovascular, endocrine and nervous systems, these physiological homeostatic innate immune mechanisms are called "para-inflammation", identifying the self-limiting active inflammatory response that leads to the restoration of the basal and normal functional state.

If decompensated, para-inflammation can become inflammation resulting in clinical pathology as seen in various chronic pathologies, including type 2 diabetes and cardiovascular pathologies. At the level of the ocular surface, with aging8, a persistent dysregulation of para-inflammation is established, resulting in the inability of the ocular surface to maintain homeostasis and leading to an asymptomatic inflammatory condition, InflammAgeing. InflammAgeing is a chronic, systemic state of low-grade inflammation and is one of the main risk factors for the development of major age-related pathologies10, for example diabetes, atherosclerosis, Alzheimer's disease COPD and alterations of the ocular surface.

Despite the positive outcomes in cataract surgery, signs and symptoms of post-operative ocular surface discomfort emerge

Many patients who undergo phacoemulsification, the most common procedure performed in ophthalmology units, suffer from dry eye and irritative symptoms postoperatively. Generally, symptoms and signs of dry eye appear 7 days after surgery and their severity increases over time7.

In the normal management of patients after cataract surgery, all subjects will be treated with the standard postoperative protocol which consists of the 1st postoperative week with topical chloramphenicol; tapering topical steroids, as per hospital protocol, 4 times a day for 5 days, then 3 times a day for the next 5 days, then 2 times a day for 5 days, and 1 time a day until the 20th day postoperative. Furthermore, any adverse events will be evaluated from the first visit to the last.

Start and end date

Project Manager

Coordinating institution of the project

Funding source(s).

Economic value of the project

130.000 €

Link to the project website

Clinical Trials register - Search for eudract_number:2019-001660-30