Ora offers comprehensive training, certification and management of all study BCVA (best corrected visual acuity) activities from start to finish.
We have experience developing standard and customized BCVA protocols. We have also developed processes for various types of acuity testing, outside of the standards laid out in the ETDRS protocol.
When visual acuity is an end-point for a clinical trial, it is critical that it is measured and collected in a standardized way. The ETDRS chart and protocol was developed in order to address issues with acuity testing (e.g. use of Snellen charts). The ETDRS chart and protocol standardizes light intensity; number, size, contrast and shape of the optotypes; and design of the test chart. By standardizing these factors and using this chart type it allows for precise quantification of vision and reliable measures of vision change. This is currently the “gold standard” in clinical research recognized by the FDA.
Standardization is essential. We need to control for the conditions in which we are testing visual acuity and performing manifest refraction. Our process utilizes calibrated equipment, photo documentation and yearly recertification to ensure standards are met and maintained.
Lane certification kit. The equipment we use for lane certification and recertification is all calibrated yearly. Calibration further ensures that lane measurements and testing conditions are all standardized.
Ora Lane Markers. We use Ora lane markers to indicate chart positioning and subject positioning. We may also add additional markers depending on the lane set up. These further ensure that there is consistency each time a subject is tested.
Example of customized near testing set ups
