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CLINICAL EVALUATION OF THE RAPID ACCESS VITREAL INJECTION GUIDE: A Handheld Instrument for Assisting Intravitreal Injections

Han, Dennis P. MD; McKenney, Kaitlin C. MS; Kim, Judy E. MD; Weinberg, David V. MD; Musch, David C. PhD, MPH; Singh, Ravi S. J. MD

doi: 10.1097/IAE.0000000000001229
Original Study

Purpose: The Rapid Access Vitreal Injection (RAVI) guide combines the function of an eyelid speculum and measuring caliper into a single instrument for assisting intravitreal injections. This study clinically evaluated the RAVI guide with respect to patient acceptance, complication rates, and operative goals.

Methods: A prospective study was performed on 54 patients undergoing intravitreal injections using the RAVI guide (n = 32) or the speculum/caliper (n = 22). Device-related pain was assessed using the Wong-Baker scoring system, scaled from 0 (no pain) to 10 (agonizing pain).

Results: Mean device-related pain score did not differ significantly between the 2 groups, with scores of 0.6 and 0.7 for the RAVI guide and speculum groups, respectively. The rate of significant pain (score of ≥2) was twice as high in the speculum group (7 of 22, 32%) compared with the RAVI guide group (5 of 32, 16%), but this difference was not statistically significant (P = 0.19, Fisher's exact test). Operative goals of avoiding needle touch to lashes/lids and guiding needle insertion to the intended site were achieved in all patients.

Conclusion: The RAVI guide appeared equivalent to the eyelid speculum in achieving operative goals, with similarly low pain scores. It has the potential for facilitating efficient, accurate, and safe intravitreal injections.

Supplemental Digital Content is Available in the Text.The Rapid Access Vitreal Injection guide combines the function of an eyelid speculum and measuring caliper into a single instrument for assisting intravitreal injections. It has the potential for facilitating efficient, accurate, and safe intravitreal injections.

*Department of Ophthalmology, Medical College of Wisconsin, Milwaukee, Wisconsin;

Departments of Ophthalmology and Visual Sciences, and Epidemiology, University of Michigan, Ann Arbor, Michigan; and

Retina Associates, PA, Shawnee Mission, Kansas.

Reprint requests: Dennis P. Han, MD, Department of Ophthalmology, Medical College of Wisconsin, 925 N. 87th Street, Milwaukee, WI 53226; e-mail: dhan@mcw.edu

Supported in part by an unrestricted grant from the Research to Prevent Blindness, Inc, New York, NY (Medical College of Wisconsin); the Jack A. and Elaine D. Klieger Professorship in Ophthalmology (Dr. Han), and the Thomas M. Aaberg Retina Research Fund (Medical College of Wisconsin).

The RAVI-Guide is the subject of U.S. Patent Application No. 13/918,473 filed on June 14, 2013 and entitled “Rapid Access Vitreal Injection Guide.” The Medical College of Wisconsin holds intellectual property rights on the RAVI Guide. R. S. J. Singh and D. P. Han are coinventors and may receive payments from the Medical College of Wisconsin resulting from commercialization of the device. The remaining authors have no conflicting interests to disclose.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.retinajournal.com).

ClinTrials.gov number for RAVI Guide Study: NCT02196584.

MCW IRB Protocol Registry number: PRO00021075.

© 2017 by Ophthalmic Communications Society, Inc.