Year : 1994 | Volume
: 42 | Issue : 1 | Page : 1-
Collaborative eales' disease study
|How to cite this article:|
Das T. Collaborative eales' disease study.Indian J Ophthalmol 1994;42:1-1
|How to cite this URL:|
Das T. Collaborative eales' disease study. Indian J Ophthalmol [serial online] 1994 [cited 2023 Jun 10 ];42:1-1
Available from: https://journals.lww.com/ijo/pages/default.aspx/text.asp?1994/42/1/1/25590
Rapid advances in eye research have stimulated many clinical trials in recent years. The collaborative multicentre Diabetic Retinopathy Study (DRS) sponsored by the National Eye Institute (NEI) in the USA has become the model and impetus for later clinical trials in disorders that affect all systems of the eye.
The goal of clinical research is to provide information that helps the clinician offer more effective treatment for patients. Clinical trials provide the best means to quantify and compare objectively the benefits and risks of new or alternative treatment for diseases. This is particularly valuable when the difference between a new and traditional treatment is not clear, and a large number of known or unknown factors may influence the course of the disease or the outcome of the treatment.
The critical component of clinical trials is their design. A well-designed and well-conducted clinical trial has to essentially incorporate high ethical standards, have concurrent control groups, random assignment of patients to study and control groups, mask the examiner to minimise any bias, recruit clinically and statistically significant number of patients, complete the follow-up and use accepted biostatistical methods for data analysis. While designing the research methodology, patient welfare and informed consent should be assigned highest priority.
The results from clinical trials provide information on the natural course of disease, efficacy and possible risks of treatment modalities, as well as guidelines for therapeutic intervention. They do not necessarily predict the course that an individual patient would follow. Thus, randomized, controlled clinical trials offer the practitioner objective and accurate information about a disease and the most effective treatment.
A strong case exists for a collaborative clinical trial in Eales' disease. Described over a century ago, this disease is still poorly understood in terms of epidemiology, aetiopathogenesis, natural course, and standardized treatment plan. This disease was initially seen in England and described by the British ophthalmologist, Henry Eales, with occasional reports from Canada and the USA. For reasons poorly understood and explained, it is now confined to Southeast Asia and is often associated with poor general health, improper sanitation, and exposure to tuberculosis. However, no accurate data is available. Thus, sporadic patients are empirically treated with anthelmintics and anti-tuberculosis drugs. The disease has a predilection for young males, involving both eyes, causing gross reduction of vision, or even blindness. The diagnostic criteria are only clinical, based purely on the findings of periphlebitis or vitreous haemorrhage in young men. No specific laboratory investigations are identified, Isolated attempts, both clinical and laboratory, have been made by various investigators to study the aetiology and the modes of treatment, but such efforts have suffered from lack of appropriate design and implementation. These have provided neither an undisputed and uniform answer nor a standard mode of treatment for this problem.
It is against this background, that an effort can be made for a well-designed, multicentre collaborative study on Eales' disease to look into various aspects such as the epidemiology, natural course and treatment. It is possible, with the available expertise and infrastructure, to conduct such a study. The support of ophthalmologists and other eye care professionals is essential in referring patients, encouraging the enrolled patients to remain in the trial, and participating in the follow-up care. Such a support will be beneficial both to the patients and the practitioner by facilitating the proper completion of the study, which in turn, will help in controlling the blindness from this disease. A major constraint for such a study has been inadequate funding and improper utilization of available funds, It is time that the participating and the resource centres for Collaborative Eales' Disease Study (CEDS) be identified and the national medical research funding agencies extend their support. Clinical trials are expensive, time consuming, difficult to perform, and yet, when done assiduously, are invaluable, for they provide the foundation for uniform clinical practice.