IN THE NEWS

Woodstock, Illinois – Precision Vision, Inc., a world leader in vision testing tools and devices, announces the transition from fluorescent bulbs to energy-efficient LED bulbs in its traditional ETDRS® Illuminator Cabinets in response to the European Union’s Ecodesign Directive and the U.S. Department of Energy’s fluorescent lighting bans. This change ensures continued high-quality performance, reliability, and regulatory compliance globally for clinical trials and research.

Background on the ETDRS Study and Illuminator Cabinet

The Early Treatment Diabetic Retinopathy Study (ETDRS) is a landmark clinical trial funded by the NEI (National Eye Institute), a division of the NIH (National Institute of Health) that established the gold standard for measuring visual acuity. Precision Vision’s ETDRS® Illuminator Cabinet has maintained these standardized testing conditions in clinical trials worldwide. These ETDRS® Illuminator Cabinets and Charts have been used in thousands of clinical trials, contributing to successful FDA approvals of new drugs and treatments of all disease areas.

Reason for the Change to LED Lighting

This transition was initiated in response to the European Union’s Ecodesign Directive and the U.S. Department of Energy’s ban, which began restricting the manufacture and import of fluorescent bulbs and ballast in Europe as early as September 2021, with a full commitment to elimination by August 2026. These directives impacted the fluorescent bulbs and the ballasts that support them. Sourcing these components has become increasingly difficult over the past few years, leading Precision Vision to begin working on a solution in late 2022. The new Traditional ETDRS® Retro-Illuminator Cabinet (2425Ev4) complies with global regulations and initiatives while ensuring the same, or better, performance characteristics of the previous versions. Data integrity using the 2425Ev4 model remains uncompromised and is a direct alternative in studies where previous versions are also used.

Benefits of LED Technology

• Energy Efficiency: LED bulbs are up to 70% more energy-efficient, reducing operational costs and environmental impact.
• Longevity: LED bulbs last significantly longer, reducing replacement needs and shipping costs.
• Light Stability: LED bulbs offer consistent light output, with less than 5% degradation over thousands of hours, ensuring uniform testing environments.
• Mercury-Free: LEDs do not contain hazardous materials like mercury, making them safer for disposal and use.

Supporting Fluorescent Versions

Precision Vision has secured the last global supply of General Electric (G.E.) F20T/12 fluorescent bulbs. This assures continued support for existing cabinets that use fluorescent bulbs for years to come.

Lane Certification Process and Bulb Replacement Changes

Having supplied ETDRS® Illuminator Cabinets to thousands of clinical trials, Precision Vision understands that most studies will not require the purchase of new equipment, and with new site activations, there will be a mix of cabinet versions (fluorescent and LED). Traditionally, sites using fluorescent bulbs were required to provide proof of pre-burning through logs or certificates (operating the bulbs for a period before certification to achieve a stable light output level). The “burn-in” step is no longer necessary with LED bulbs due to their inherent design stability, providing immediate and consistent luminance for longer periods of time.

Additionally, with fluorescent bulbs, sites were required to replace bulbs annually to remain compliant, while Precision Vision LED ETDRS® bulbs (2427D-V4) can extend the bulb replacement cycle for up to two (2) years.

Precision Vision understands that studies that include fluorescent and LED cabinet versions can introduce challenges when two (2) different bulb replacement policies are in place. When asked, Precision Vision will provide the replacement schedule for both types of cabinet bulbs (Fluorescent Bulbs: Annual, LED Bulbs: Biennial) but advise that sites speak directly to their Sponsor, CRO, or Certifying group to ensure they follow the requirements of their study-specific protocol.

Ensuring Authenticity and Combatting Counterfeits

All LED bulbs from Precision Vision have a unique serial number, the same as pre-burned fluorescent bulbs, for identification and verification, ensuring the use of authentic and properly calibrated bulbs. Precision Vision is aware of counterfeiters in the USA and India marketing replica bulbs. Counterfeit bulbs lack proper calibration and threaten the integrity of clinical research data for financial gain to the counterfeiter. Precision Vision is committed to protecting the quality and reliability of your research by providing serialization and maintaining sales records to ensure proof that certified OEM parts are used in your studies to maintain the highest standards and uniformity for visual acuity testing.

Precision Vision takes extensive measures to account for all variables in the design of the ETDRS® Illuminator Cabinets—including all materials and components. These efforts ensure that all study sites around the globe experience uniform performance, which is essential for reliable clinical trial data.

Contact Us

For any questions or additional information regarding the LED transition, don’t hesitate to get in touch with Precision Vision at [email protected] or 815-223-2022.

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