Methodologies for interventional myopia studies

Myopia studies are notoriously difficult to carry out. Past studies on intervention in myopia progression have given conflicting results. Beside inaccurate and inadequate measurements, the most important cause for this is the very variable nature of myopia, which makes it difficult to achieve baseline comparability between the control and the study group. Although there were inclusion criteria in these studies, for age, sex, race, degree of myopia and stigmatism, the most important variate-- the rate of myopia progression-- was not included. Randomisation can achieve baseline comparability of the myopia progression rate, provided the sample sizes are large enough. Unfortunately, past studies have been limited to 100 to 200 children only. Studies on twins are more reliable than random groups because myopia progression rates are more likely to be the same in a pair of twins. Studies on the same subject, comparing the right eye and the left eye would be even better, but this method is practicable for some studies only (e.g., we cannot have a spectacle lens for one eye and a contact lens on the fellow eye). There is another method of doing an interventional study on myopia. Because myopia progression is linear in its early stage until the early teenage years, it is possible to observe what happens to the linear progression upon intervention. In this way, we avoid the problem of trying to compare "apples with apples" but use the "same apple" instead.

Ethical issues in ophthalmology and vision research

As more research work is done on eye disorders, more safety rules and regulations are required to ensure the safety of trial subjects. This is the main function of Research Ethics Committees [also known as Institutional Review Boards (IRBs) and Domain Specific Review Boards (DSRBs)]. Tragedies in research in other fields are wake-up calls, such as the death of a healthy young volunteer subject in New York, the termination of a large study sparked by breach of medical confidentiality in Singapore and the South Korean debacle of its pioneering work in cloning. Many issues are still being debated, such as what statutory changes are required to control trials; whether all trials should be reviewed by IRB; if phase IV trials should be exempted; if compensation should be paid for all trial-related injuries; and whether investigators and IRB members be allowed to hold certain amount of shares in drug or device firms. Recent measures taken to prevent ethical problems include funding organisations not approving a study unless it has been cleared by the IRB, and requiring all investigators and IRB members to pass an ethics course. More measures will need to be taken to ensure the safety of the trial subjects involved in research studies.