Enhancing Clinical Trials
Good-Lite is the trusted global standard in vision testing devices, relied on by clinical researchers for over 95 years. With unmatched reliability and proven performance, Good-Lite empowers CROs and sponsors to generate data that stands up to the highest clinical and regulatory scrutiny.
Why Good-Lite
Choose Us for Your Clinical Trial
Good Lite instruments are engineered to meet and exceed the strictest vision testing protocols used in clinical research, enabling consistent, reproducible results across sites:
Over 100 published studies have validated the CSV 1000’s use for cataracts, glaucoma, sports vision, IOLs, refractive surgery, contact lenses, and drug trials
Featured in 50+ FDA-registered clinical trials and used by clinicians on 4 continents
Good-Lite vision testing devices are installed in more than 10 000 eye-care sites worldwide, and it’s regularly selected for multi-center study protocols
Clinical Trials
Supporting and Facilitating Clinical Trial Processes
We understand the operational demands of clinical research. That’s why Good-Lite offers trial-ready services designed to streamline procurement, support protocol consistency, and ensure regulatory alignment from Phase I to post-market studies.
Good-Lite’s quality assurance program ensures every instrument performs to protocol standards—every time—by using precision-controlled manufacturing, conducting 100% quality control testing on critical components, and maintaining full traceability from component sourcing to final inspection.
Transparent fulfilment timelines and rapid international shipping help you stay on schedule, even across multiple trial sites. Including Turnkey international delivery.
Pre-bundled components aligned to your protocol, including calibrated charts, lighting systems, and testing tools—packaged for immediate deployment.
All critical components include lot tracking and documentation to support regulatory audits and Standard Operating Procedure alignment
Maintain protocol fidelity with consistent reordering options for multi-phase or follow-up research.
Get volume pricing and CRO-specific configurations tailored to your study’s needs.
Our field-reported defect rate consistently outperforms established standards
Good-Lite Warranty: Quality You Can Trust and Depend On
In the event that a product is found to be defective under warranty within two (2) years of purchase, Good-Lite guarantees the dispatch of a replacement unit from our warehouse within 24 hours of confirmation. This commitment is designed to minimize operational disruption and ensure uninterrupted continuity of your research or clinical activities.
Product Highlight
Retro Illumination LED™
Uniform, controlled lighting is vital for clinical accuracy. That’s why Retro Illuminated LED technology is essential. Unlike front-lit or edge-lit LED charts used by competitors, retro illumination provides consistent luminance across the entire test plate, eliminating hot spots and edge dimming that can compromise test reliability and skew results.
Why It Matters
Good Lite’s Retro Illuminated LED maintains ±5% uniformity across the entire plate area, with optional automated calibration to ensure reliable, repeatable results—especially critical for multi-site studies where consistency is paramount.
Ensuring Data Continuity
Good Lite’s Retro Illuminated LED Cabinets are designed to match the luminance and photopic standards of older fluorescent devices. This guarantees that data from our LED technology is comparable to results from past studies, maintaining the integrity and consistency of research across generations.
ESC2000™ Illuminated ETDRS Clinical Trial Cabinet
Distance ETDRS Evaluation
The ESC2000™ is engineered for ETDRS accuracy, it provides 85 cd/m² fixed luminance (±15%) with photopic/mesopic support, glare control, and internal reflectance management.
ESV3000™ ETDRS Clinical Trial Standardized Viewer
Distance ETDRS Evaluation
The ESV3000™ features a self-calibrating LED system with auto-adjusting sensors to deliver 85/3 cd/m² output (photopic/mesopic) with <±10% variance.
CSV-1000® Test Instrument Viewer
Contrast Sensitivity
The CSV-1000® auto-calibrates to 85 cd/m² (<±10% variance) for FDA-compliant contrast sensitivity testing, with support for interchangeable test faces.
CSV-1000® HGT Test Instrument Viewer with Glare Lights
Contrast Sensitivity
The CSV-1000® HGT adds glare lights to FDA-compliant contrast sensitivity testing, with 85 cd/m² auto-calibration and support for multiple test faces.
Evans Letter Contrast Test for ESV3000™ and ESC2000™
Distance chart
The Evans Letter Contrast Test (ELCT) is the first standardized letter contrast chart, designed for use with the ESV3000™ or ESC2000™ for consistent lighting.
ESV1500™ ETDRS Standardized Cabinet
Near and Intermediate Testing
The ESV1500™ features patented self-calibrating LED tech for 85/3 cd/m² output, auto-adjusting to 100–240 VAC with built-in storage and remote control.
Quality Standards
Aligning with Global Clinical Protocols
Our commitment to global standards ensures that our vision testing devices meet the highest regulatory requirements. This alignment enhances the reliability and credibility of clinical trial outcomes.
All Good-Lite devices are registered as Class I medical devices with no export restrictions from the United States. These devices are routinely used in FDA-regulated clinical trials as validated outcome tools for visual function assessment.
Good-Lite products are CE-marked under EU MDR, meeting safety, performance, and post-market requirements—ideal for EU clinical trials and international studies.
All design, manufacturing, calibration, and traceability processes are governed by an ISO 13485-certified Quality Management System—ensuring consistent, audit-ready documentation for clinical and regulatory needs.
Our charts and digital systems follow ISO 8596:2017 specs for size, contrast, and luminance, ensuring ±25% luminance variance and calibrated photopic (85 cd/m²) and mesopic (3 cd/m²) conditions.
The ESC2000, ESC3000 and CSV1000 series maintain protocol-defined luminance levels automatically—ensuring compliance with FDA and ANSI Z80.21 standards for clinical trials involving contrast sensitivity testing.
Good-Lite’s ETDRS charts in ESV3000 and ESC2000 cabinets meet 0.1 log unit spacing, ANSI/NAS calibration, and 85 cd/m² luminance—matching standards for pivotal ophthalmic and neurological trials.
All applicable electrical devices, such as the ESC2000 and ESC3000, are CSA-certified, ensuring compliance with Canadian electrical safety standards for clinical environments.
FAQs
Frequently Asked Questions
Find answers to the most common questions about our vision testing devices for clinical trials.
Is this device validated for use in clinical trials?
Yes. Good-Lite instruments have been used in hundreds of clinical trials globally. Our ETDRS cabinets, HRR pseudoisochromatic plates, and CSV-1000 contrast sensitivity systems are frequently cited in peer-reviewed research and FDA submissions.
What standards (ISO, FDA, CE, etc.) does it comply with?
Good-Lite products meet or exceed the following international standards:
- ISO 8596:2017 – Visual acuity testing
- ISO 13485 – Medical device quality management
- ISO 8253-1 – Audiometry-compatible luminance standards
- FDA 510(k) clearance for major devices (e.g., HRR, ETDRS)
- CE certification under MDR 2017/745
Is it accepted by regulatory bodies like the FDA and EMA?
Yes. Our products are routinely accepted in FDA INDs/NDAs, EMA submissions, and PMDA filings. ETDRS testing, for instance, is the gold standard for visual acuity endpoints per FDA and ICH E6(R2) guidance.
Has this product been used in pivotal or late-phase studies?
Yes. Good-Lite devices have been used in pivotal Phase III and IV trials across ophthalmology, neurology, and rare disease research. We can provide trial references on request.
Can I get a Declaration of Conformity, CE Certificate, or 510(k) summary?
Absolutely. All compliance documents, including CE and 510(k) summaries, are available upon request or for download directly from our Clinical Trials Resources page.
Can I reference your tools in my protocol or IND/IDE submission?
Yes. We provide standardized device descriptions, model numbers, technical specs, and validation citations to simplify protocol writing and IND/IDE filings.
What is the scientific basis for your tests (e.g., HRR, ETDRS, Contrast)?
Each of our tools is based on decades of vision science:
- ETDRS was developed under NIH contracts to standardize acuity testing
- HRR plates follow confusion line principles, ideal for acquired and congenital color deficiency testing
- CSV-1000 is based on spatial frequency testing validated against real-world contrast performance
Are your tools referenced in peer-reviewed literature?
Yes. Good-Lite instruments are cited in over 500 peer-reviewed publications. Visit our Research Library to explore citations by product and study type.
How consistent and repeatable are your measurements across sites?
Our devices are engineered for consistency:
- ETDRS cabinets use LED illumination with <1% luminance deviation
- Color plates are printed with digital precision—eliminating ink drift
- All units are calibrated against NIST-traceable standards where applicable
Do your tests align with clinical endpoints recognized by regulators?
Yes. Visual acuity (ETDRS), contrast sensitivity (CSV), and color vision (HRR) are all recognized by the FDA, EMA, and ICH as valid endpoints for safety and efficacy.
How do your products compare in accuracy and reliability?
Good-Lite is the only manufacturer with exclusive rights to LEA Symbols and HRR plates, and the original developer of ETDRS charts with Sloan letters.
Our devices are precision-engineered and batch-calibrated to ensure unmatched clinical reliability.
How long do the bulbs or LEDs last?
With a lifespan of 25,000 hours, these systems reduce the frequency of replacements and the associated waste, aligning with environmentally conscious practices.