Ophtec Sees Easier, More Accurate Data Collection with Greenlight Guru Clinical

The team at Ophtec is dedicated to creating best-in-class intraocular lenses (IOLs) and solutions for cataract and refractive surgery. Started by Professor Dr. Jan Worst more than 40 years ago, Ophtec is now a global company that exports its products to 99 countries around the world.

Ophtec provides a full range of standout intraocular products and services to help tackle a wide variety of vision impairments. The company’s overarching goal is to help people see clearly, and they do so by providing innovative products and support to ophthalmologists before, during, and after surgery. 

The Challenge: Paper CRFs were error-prone and time-consuming

Due to their invasive nature, IOLs are Class III medical devices in both the US and Europe, which means they require extensive clinical evidence of safety and effectiveness before they can be placed on the market.

Ophtec conducts the majority of clinical activities in-house. —a source of pride for a relatively small company. However, the team knew from past trials that data collection on paper CRFs was prone to errors and misunderstandings that cost them precious time and energy. 

“Paper can be lost very easily. It can be delayed when you have to mail it. Sometimes there are miscommunications and issues with accuracy,” said Daniel Afsharzadeh, Clinical Research Associate at Ophtec.

With a large clinical study on their Artiplus lens coming up—around 50 participants in multiple countries—the team at Ophtec knew that paper wouldn’t cut it. This time, they needed a modern, electronic solution for their clinical data collection.

The Solution: Greenlight Guru Clinical’s easy-to-use EDC system

With so much on the line, Ophtec turned to Greenlight Guru Clinical for its organized, compliant, and easy-to-use EDC system.

The team at Ophtec considered a number of EDC solutions before landing on Greenlight Guru Clinical. After speaking to the team at Greenlight Guru, they felt confident about moving forward, but what really sold them was the demo of the software.

“The demo was very convincing,” said Afsharzadeh. “We engaged our data analysis team and they also thought this was the system we should go with.”

The Results: Easy and accurate data collection from eCRFs

Once the clinical team at Ophtec began using Greenlight Guru Clinical, they knew they had found both an excellent solution and a great partner for further clinical trials of their products. 

Eliminating the paper problems

The first thing the team noticed was the absence of the usual problems and misunderstandings that come with paper-based data collection.

And that increased accuracy and organization is a major benefit to the organization. Increasing accuracy and organization means reducing the time and effort spent trying to figure out if a form was filled out correctly or whether an outlier is a data entry mistake. 

“Those problems cost an organization,” said Afsharzadeh.  “So a solution like Greenlight Guru Clinical may look costly, but it’s actually saving the organization money because of the delays and the frustration it eliminates.”

A user-friendly experience

Not only have there been no complaints from Ophtec’s team, but they’ve found that the study sites can easily use Greenlight Guru Clinical, as well.

What’s next for Ophtec?

The team at Ophtec will continue to build innovative, best-in-class products to help patients around the world see clearly. With a planned expansion of their research and development facilities, Ophtec will be carrying out many more of their own clinical studies—and Greenlight Guru will be with them every step of the way. 

As Afsharzadeh put it, “I can say we have a convincing body of evidence that we should stick with Greenlight Guru Clinical.”