M&S Technologies’ DVA-5000 delivers unbiased data.

Clinical researchers have a new tool with the launch of the M&S Technologies Clinical Trial Suite (CTS) DVA-5000 module. This computerized system integrates validated M&S Technologies’ visual acuity testing algorithms for use in clinical trials and research. The module provides computer-automated Early Treatment Diabetic Retinopathy Study (ETDRS), Electronic Visual Acuity (EVA) and contrast sensitivity (CS) testing.

“We created the DVA-5000 for retina and glaucoma researchers, clinical trial sponsors and private practice research clinicians who require consistent, unbiased test results from visit to visit and site to site,” says Joseph Marino, MBA, BS, founder and global head of M&S Technologies, Niles, Ill.

CTS has been used in more than 140 ophthalmic clinical trials, and the FDA recognizes it as an acceptable method of vision testing in all phases of clinical trials, including PMA trials.

CTS testing modules offer state-of-the-art diagnostic technologies and digital monitoring systems for studying medications, the company says. “As a principal investigator, I have used CTS testing modules in presbyopia and IOL trials per sponsors’ requests,” says David Evans, OD, president of Total Eye Care, PA, in Memphis, Tenn.

HOW IT WORKS

The DVA-5000 was designed to meet the needs of sponsors of retina and glaucoma clinical trials by improving ETDRS test accuracy and including contrast function testing that is accurate, validated and time-saving. Retina and glaucoma subspecialty trials may include testing such as optical coherence tomography, visual fields, IOP measurements and photography.

“Although these trials include visual acuity testing, sponsors aren’t aware of the speed, accuracy and efficiency of CTS, ETDRS, EVA and CS testing,” says Joseph P. Gira, MD, at Ophthalmology Consultants in St. Louis, who also uses the DVA-5000. “There is evidence^1-4 that CS testing documents changes in neovascular AMD, intermediate AMD, branch retinal vein occlusion and glaucoma. CTS CS testing is fast and accurate, or it wouldn’t be used in so many trials.”

All testing on the DVA-5000 is preprogrammed to meet the requirements of the sponsor, researcher or investigator site. Test results with customized analysis are available in formatted letter score, logMAR, decimal score and Snellen equivalent. Sponsor-customized reports are secure, encrypted and immediately available for export or upload to an electronic data capture site (EDC) in .XML or .CSV formats.

A customized preprogrammed control tablet is Bluetooth connected to the DVA-5000 system with protocol requirements. Tablet instructions guide technicians through all aspects of testing for a trial’s duration, Dr. Evans explains. Test data is entered directly to the tablet, saving time compared to using a standard light box with paper test-score documentation. Technicians cannot deviate from the protocol, which has caused trial errors previously, he notes.

The tablet allows for easy data entry based on a subject’s responses and a reaffirmation point to verify the entered data, Mr. Marino says. The technician simply enters the number of letters that are correct as the subject advances through the ETDRS chart. The DVA-5000 eliminates manual calculations, all data entry and technician bias. It can be configured for automatic test result uploading.

ADVANCED AND INNOVATIVE

According to Mr. Marino, CTS modules, including the DVA-5000, are popular among clinical trial sponsors because they offer a preprogrammed computerized solution that reduces test time, increases throughput and eliminates technician bias and erroneous data entry errors. The end result is an increase in quality of data with repeatable results.

The DVA-5000 is calibrated for both distance-to-subject and pixels-per-inch; therefore, optotypes precisely follow ANSI Z80.21-2010 (R2015), ISO 8596:2017 and ISO 10938 regarding size, spacing between optotypes and spacing between lines. The system offers Sloan letters or British Standard Institution letters; the randomized presentation of letters or symbols eliminates the memorization effect. Letter contrast system luminance is automatically calibrated, and ambient room conditions are measured with a luminance sensor. Background luminance is calibrated to 85 cd/m2 for standardized ANSI and ISO testing and is customizable to any distance.

The fully customizable CTS and DVA-5000 software platform can accommodate additional testing modules, if changes to the protocol occurs.

OTHER BENEFITS

Although many clinical trials include the same tests, sponsor protocols are always different. “That’s why the CTS system is so unique,” Dr. Evans says. “All our CTS systems are programmed to precise protocol requirements. With the number of trials we participate in, using the DVA-5000 as well as the other CTS systems keeps everything on track, efficient and organized.”

All CTS systems are customized and programmed to a trial’s specifications, Dr. Gira adds. No one, including the principal investigator, can change the type or order of tests. The software is programmed to perform participant tests in a specified order and documents the number of days between site visits. Test results are automatically calculated, and reports are uploaded to an EDC site or reading center.

“Sponsors use CTS testing because subject outcome measures are consistent throughout the trial across all participating sites,” Dr. Evans says. Standardized reporting provides biostatisticians with immediate calculated report data. This allows sponsors to quickly make changes to protocol testing if needed as well as provide faster access to outcome trends.

“When used in routine clinical trials, the DVA-5000 provides fast assessment of contrast sensitivity, which is directly related to quality-of-life assessment,” Dr. Evan says. “The sooner this is addressed, the better patients can function in their daily lives.” OM

REFERENCES

1. Vingopoulos F, Wai KM, Katz R, Vavvas DG, Kim LA, Miller JB. Measuring the contrast sensitivity function in non-neovascular and neovascular age-related macular degeneration: The quantitative contrast sensitivity function test. J of Clin Medi. 2021;10:2768.
2. Ichhpujani P, Singh T, Thakur S, Singh RB, Kumar S. Assessing glaucoma deterioration using Spaeth/Richman contrast sensitivity test. Ther Adv Ophthalmol. 2020;12:2515841420977412.
3. Tochel CM, Morton JS, Jay JL, Morrison JD. Relationship between visual field loss and contrast threshold elevation in glaucoma. BMC Ophthalmol. 2005;5:22.
4. Silverman RF, Kasetty M, Vingopoulos F, Katz R, Cho J, Lesmes LA, et al. Measuring contrast sensitivity function with active learning in retinal vein occlusion: a new endpoint of visual function. Ophthalmic Surg Lasers Imaging Retina. 2020;51:392-400.