Capabilities

Optym Ophthalmic Certification provides services for training and certification in the following tasks:

  • Standard and Electronic ETDRS Refraction
  • Standard and Electronic ETDRS Visual Acuity
  • Pelli Robson Contrast Sensitivity
  • NEI Visual Function Questionnaire 25 (NEI VFQ-25)
  • Short Form 36
  • Tonometry
  • Berkeley Rudimentary Vision Test(BRVT)

Optym maintains a database that includes more than 1500 clinical centers worldwide (both academic institutions and private practice settings) and the certification status at each of these clinical centers.

This extensive resource enables Optym to quickly assess the readiness of a clinical center to begin screening and enrolling patients and to easily identify those centers where staff would benefit from personalized training that lead to certification.

Optym certifies clinical center staff via site visits, training/certification meetings or by way of grandfathering from other clinical trials certified by Emmes. Emmes also trains sponsor monitors to assess the ophthalmic facilities to ensure compliance with the study protocol.

Purpose:

The purpose of the Ophthalmic Clinical Trial Training and Certification (OCTTC) group at Emmes is to certify clinical center staff participating in ophthalmic studies who need to obtain important visual function data in a standardized way.  Certifications are obtained via site visits, grandfathering from existing Emmes certifications, training meetings or by telephone/webinar.  The OCTTC most commonly certifies clinical center staff in refraction and visual acuity, as visual acuity is usually the primary endpoint in many ophthalmic clinical trials.

Use of the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol for performing manifest refraction and assessing visual acuity serves as the gold standard in the conduct of ophthalmic clinical trials.  The protocol helps to assure uniformity of measurements when gathering important outcome data.  Study sponsors are assured that personnel at clinical centers are applying the protocol correctly.