The Pretoria Eye institute has a vibrant and busy research department, serving the research and development companies well for almost two decades already. When pharmaceutical companies research and develop a new drug or pharmaceutical intervention, the drug is subjected to extensive laboratory testing, and then testing on healthy volunteers occurs. Finally, in what is termed second phase(short term studies) and third phase (long term studies) clinical research, the drug or intervention is tested on patients, usually worldwide and within the constraints of a tight protocol, and always under the watchful eye of the Federal Drug Association (FDA-America) and the South African Health Products Regulatory Authority (SAHPRA). This is generally where the Pretoria Eye Institute becomes involved. This level of study is usually to confirm that the medication is safe and effective to be used for a specific condition.
The investigators are identified by the relevant pharmaceutical company or clinical research organization, given detailed training in that specific protocol, and asked to recruit patients, complying with strict inclusion and exclusion criteria. Although only a few doctors are enlisted as investigators, the whole Pretoria Eye Institute is involved in the recruitment of patients. The strict adherence to the protocol and inclusion and exclusion criteria is essential to ensure that patients all over the world are similar with regard to the condition under study, treated exactly the same, examined in the same way ant that the findings are therefore comparable. At all times the patient’s continued safety and control of the disease takes precedence over any other study item, and participation is always voluntary and free of charge.
Most of the drugs that you use during the course of an illness or in your day to day life have been subjected to drug trials, ensuring their safety and efficacy. In fact, the drops you may have put in your eye today, or the operation that you might have had at the Pretoria Eye Institute might have worn their training shoes at this Institute! The Pretoria Eye Institute was one of the top patient recruiting sites for the now widely used drug, Posuredex, when its effectiveness for a variety of eye conditions, resulting in macula swelling, was first tested 8 years ago.
Through the years the Research Unit has done many different studies, testing different eye drops or procedures. Children with seasonal conjunctivitis have been tested for a more effective treatment. Patients who have suffered a stroke of occlusion in the eye were treated with Posuredex, now a registered drug, as have diabetic patients with macula oedema. One of the most dynamic fields of research has been in the field of glaucoma, and some drugs that you use today, such as Lumigan and Xalacom were tested here at the Pretoria Eye Institute along with other international sites. Comparative studies are also done to determine the Gold Standard. Which drug is really the best for that specific indication? We are currently busy with such a study comparing two registered drugs best suited to the treatment of Diabetic Macular Oedema.
To find out more about clinical trials, follow the link below: www.sanctr.gov.za which is a national clinical trial register.