Research
For more than a decade, the Pretoria Eye Institute has been involved in
several international and local phase 2 and phase 3 clinical research
studies. Over 300 patients have been enrolled in these studies, some of them
doing long haul studies for as long as 3 years. Various procedures and
treatment interventions that are now common place in eye treatments, such as
intra-ocular lowering drugs were first tested following stringent protocols
at the Pretoria Eye Institute.
Patients for these studies are
recruited by the primary ophthalmologists as well as from doctors and
clinics in the surrounding areas. They are screened and need to comply with
strict inclusion and exclusion criteria prior to study involvement. Safety
and efficacy are primary areas of data collection in phase 2 and 3 studies
and many examinations and special investigations to ensure the patients
well-being are done. Data collected is submitted to the relevant Clinical
Research Organization under the scrutiny of the Medicine Control Council of
South Africa, the various Ethics bodies and the FDA of America and any other
relevant governing bodies.
Amongst others, major studies done in the
past decade have included the pharmacological treatment of seasonal
conjunctivitis, vernal kerato-conjunctivitis, several glaucoma modules of
treatment such as trabeculectomy followed by pharmacological interventions,
and five IOP lowering topical medications. More recently, in the past 5
years, the Pretoria Eye Institute has become involved in clinical trials
with intravitreal injections for the treatment of various conditions,
such as Retinal Vein Occlusion and Diabetic Macula Edema.
The
Pretoria Eye Institute is also involved in sub studies, where there is
concern regarding the possible ophthalmic involvement of a non-eye related
condition, such as Parkinson's and schizophrenia and an investigation
product. The responsibility of the Research group is then to do a thorough
eye examination, special investigations as pre-determined by the sponsor
company and submit the data for safety collection. All this data is
collected end forms part of the information given with each drug.
Doctors at the Pretoria Eye Institute are also involved in their own
independent studies. They have to submit their hypothesis and protocol for
approval, work under an ethics committee if new medications or procedures
are involved, and submit their data to an independent statistical department
for analysis. Much of the information collected in this manner is then
shared with colleagues at conferences or in the form of articles, published
in leading medical journals.
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