Our knowledge about the eye increases every day, leading to remarkable advances in treatments for conditions affecting sight.
For people living with age-related macular degeneration or diabetic retinopathy, intraocular drug therapies (injections) have transformed their disease management. Similarly, patients with glaucoma and dry eye disease have new drug and surgical options to choose from that weren’t available to earlier generations.
These advances in eye health screening, diagnosis, prevention and treatment are made possible by clinical testing or ‘trials’ using human volunteers.
In a clinical trial, participants receive specific interventions which may include medical products (drugs or devices); procedures; or instructions to change their behaviour (such as diet).
Some trials compare a new medical approach to one that’s already available, to a placebo that contains no active ingredients, or to no intervention at all. Some clinical trials compare existing therapies to each other.
Investigators aim to determine the safety and efficacy of an intervention by measuring certain outcomes in the participants. This helps to determine if a new approach works, if it’s safe and if it’s better than what is already available. Clinical trials used in drug development are sometimes described by phase.
A clinical trial runs according to a plan known as a ‘protocol’. The protocol describes what’s being investigated and safeguards participants’ health.
The protocol includes:
Clinical trials for eye health therapies can be particularly complex, with assessments of subjective elements such as a participant’s vision and comfort levels and other objective tests such as changes in corneal thickness.
Researchers give participants detailed information about a clinical study to help them decide whether they want to enrol or continue in a study. This document is called ‘informed consent’. This step should provide enough information for a person to understand the risks, potential benefits and alternatives to the study.
In addition to the informed consent document, each clinical trial might have recruitment materials, verbal instructions, question-and-answer sessions and activities to measure participant understanding.
Participating in a clinical study contributes to medical knowledge. Clinical trial results can impact the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions.
Clinical trials provide the basis for the development and marketing of new drugs, biological products, and medical devices.
Some trials may provide participants with the prospect of direct medical benefits, while others do not.
As part of its commitment to eye health research and saving the sight of future generations, QEI participates in multi-centre clinical trials regularly. For more information about clinical trials at QEI visit our website here