The IOBA clinical area receives every year more than 18.000 visits and our historical medical record archives in made by more than 60.000. All these patients are available for Vision R&D. But also to facilitate the enrollment of those named “naïve-patients” IOBA has established an agreement with the Hospital Clinico Universitario of Valladolid, its satellite the Medina del Campo Hospital and the East Area of Primary Care of Valladolid. In brief, we have access to 235.000 inhabitants.
These patients have some important demographics characteristics, including their old age. Therefore ageing processes and age related diseases are present with a high prevalence in this population, when compare with some other areas of the world. More than 23% of the population is 65 y.o. or older.
Also the area of influence of the IOBA extend to close counties such as Zamora (185.000 inhabitants), Segovia (159.000 inhabitants), and the West Area of Valladolid, therefore in some cases our influence are could be estimated in more than 1.0 million people.
As mentioned, prevalence of those ocular disorders related to ageing process is very high at our influence area, and dry eye syndrome is a good example.
Although prevalence of eye syndrome in adult population has been estimated in 8,7%, this rate increases up to 30% in population over 65 y.o. due to many causes including ageing and the concurrence of many other factors including the necessity of systemic medications with clear effects on tears production and the increase of chronic ocular disorders, such as glaucoma, requiring long term topical medications.
Due to the above mentioned characteristics, our company has a high capacity of recruitment of naïves patients, guaranteeing a control of time for your clinical study. Even more our preferential relations with some of the Spanish ocular patient’s organizations through the IOBA (Eye Institute) make us an adequate site for recruiting complex cases.
IOBA also coordinates an on-line course for training study coordinators designed by the Spanish Ophthalmological Collaborative Research Network (Oftared.com) which guarantee the existence of adequately trained personal to be assigned to any clinical study from the beginning.
Vision R&D coordinates with the IOBA has the experience of developing multicentric clinical studies, acting as a promoter. In fact IOBA developed the first official investigator-driven clinical trial for the Spanish Ophthalmology (Retina 3, project Pastor JC, Lopez-Galvez MI. [Efficacy and safety of intravitreal injection of triamcinolone acetonide as treatment for diabetic diffuse macular edema Arch Soc Esp Oftalmol 2009 ;84:547-548]. And currently we are coordinating a multicentric study named Retina 4 project which has released many papers [Rojas MJ, et al. Development of predictive models of proliferative vitreoretinopathy based on genetic variables. The Retina 4 project. Invest Ophthalmol Vis Sci 2009; 50:2384-2390. Rojas J, et al A Strong Association in the TNF Locus with Proliferative Vitreoretinopathy. The Retina 4 Project. Ophthalmology 2010;117:2417-2423. Pastor-Idoate S, Rodríguez Hernandez I, Rojas J, Fernandez I, García Gutierrez MT, Ruiz Moreno JM, Rocha Sousa A, Ramkissoon Y, Harsum S, MacLaren RE, Charteris D, Van Meurs J, Gonzalez Sarmiento R, Pastor JC. The p53 codon 72 polymorphism (rs1042522) is associated with proliferative vitreoretinopaty. The Retina 4 project. Ophthalmology. 2013 Mar;120(3):623-8]. For this study, (Retina 4) currently on-going , we coordinate centers from Spain, Portugal, Holland and United Kingdom.
With this experience we are able to work together with our customers improving their original protocols or designing them from the beginning. We can advise the customer in the selection of the most appropriate outcomes, providing the highest probability to show clinical significance, and even to prepare the data collection notebook.
Our statistical unit has also a high experience in calculating samples, and analyzing data, by simple or sophisticate techniques [Sanabria MR, et al. A Propensity Score Matching application: Indications and results of adding scleral buckle to vitrectomy. The Retina 1 Project: Report 3. Eur J Ophthalmol. 2011:22; 244-253] And they are fully familiarized with the commonest ocular diseases and problems which facilitates the communication and exchange of data.
Orus, an independent CRO based in Spain, and fully oriented to Ophthalmology and Visual Sciences has an agreement with the IOBA and Vision R&D. This CRO has experience in European Union funded grants and through Oftared offers a large variety of animal models of many ocular diseases, most of them fully validate. Rates of this CRO are affordable.
Finally, Vision R&D makes the appropriate final report after deep data analysis and discussing the conclusions with our customers.