January is National Glaucoma Awareness Month. Glaucoma is estimated to affect more than 3 million Americans each year, and at least half of those do not even know they have it because glaucoma usually has no symptoms until the disease has progressed to a late stage. Glaucoma is an important health concern, as the disease is one of the leading causes of blindness in the United States.
Clinical research in glaucoma and other ophthalmologic diseases is key to better understanding eye disease, identifying preventive measures, learning how to identify and treat diseases in early stages and developing new therapies and treatments to reduce the likelihood of debilitating complications and blindness. The Mednet team has significant experience in ophthalmology. Over the years, our team has supported research across the world and hundreds of studies in ophthalmology, related diseases and treatments have been conducted on the iMednet platform. Furthermore, Mednet’s experience in ophthalmology is wide-ranging, inclusive of device, biotech and pharmaceutical studies.
Ophthalmology studies are unique in many ways. They are often comprised of large forms that typically collect data for BOTH eyes, treating one or both eyes, or one eye then the other based on results. These studies tend to be complex with many forms, but there are also often a lot of similarities between studies.
Mednet’s platform is well-suited to support the nuances of these types of studies. Its validated study replication tools enable customers to get their ophthalmology studies up and running quickly. Form design can use business logic to enable or disable appropriate eyes. Mednet’s dynamic grids can be helpful to address “by eye” or for “crossover treatment”. If desired, Mednet also has the ability to display study eye on all pages. If study eye is the right eye and only data for the right eye is collected after screening / study eye selection, Mednet can also hide data collection for the left eye.
Given these tools and the overall flexibility of the platform, along with the team’s extensive experience running ophthalmology studies, Mednet is well-positioned to enable research teams to build and conduct their glaucoma and other eye studies with ease. Recently, our team was able to get a study up and running for an existing ophthalmic medical technology sponsor in less than three weeks using study replication tools. This particular sponsor heavily leverages Mednet’s form library, using standard forms that can be replicated and imported for ocular assessments, dramatically increasing efficiency on all study builds.
Mednet’s tools and experience can also help new ophthalmic customers. Often eye assessments are standard across clients and studies, and even if an ocular study is building for the first time, we can often use another similar study’s case report form (CRF) as a starting point, saving significant time and resources.
For a recent pharmaceutical study conducted by an ophthalmology CRO, the protocol included two parts: part one was non-randomized with shorter follow-up period, and based on the results, they proceeded to part two, which was randomized with a longer follow-up period. To address this unique design element, our team worked with the CRO to leverage the dynamic grids (one grid for part one and a second grid for part two) in iMednet. In addition, using Patient ID configuration and keywords, users can tag records / patient in the background, based on specific conditions. From there, it is easy to control many things in the database, such as fields, forms, intervals, reports, etc., and for this study, it made it very easy to identify in data export and reports which part the subject was in.
Technology can significantly streamline processes and improve efficiency in all studies, but particularly in ophthalmology studies given their unique design considerations. Therapeutic area expertise is also important. Mednet is proud to have conducted hundreds of ocular studies on its platform, and several of our team members have deep experience in ophthalmology. To learn more about Mednet’s flexible platform or our therapeutic expertise, contact us.